Your Surgery Planner

another step
forward
RECONSTRUCTION
SURGERY
WITH NATRELLE ®
SILICONE-FILLED
BREAST IMPLANTS
 L

PL A C E Y OU R IDE N TIFIC ATI O N CAR D ( S) H ER E

R
int r o d u c t io n
Dear Patient,
Allergan has developed this RECONSTRUCTION SURGERY WITH
NATRELLE ® SILICONE GEL-FILLED BREAST IMPLANTS PATIENT PLANNER
to function as a resource for all aspects of your surgery. Please give
yourself at least 1 to 2 weeks time to consider this information before
deciding to proceed with surgery unless an earlier surgery is deemed
medically necessary by your surgeon.
This patient planner should serve primarily as your source of information
on the risks and benefits of surgery with NATRELLE ® Silicone-Filled Breast
Implants but also as a convenient place where everything necessary for
planning, follow-up and keeping can be securely stored.

The information contained in Section I is intended to provide you with an

understanding of the risks and benefits of surgery with silicone gel-filled
breast implants, as well as provide an overview of the experience of
patients in the Allergan Core Clinical Study.

Please thoroughly review this

information. Following your
review, complete the Patient Self
Assessment. This assessment
will help determine your
understanding of the information
presented and help your surgeon
ensure that your preoperative
consultation is effective and
comprehensive. Make notes
about issues that you would like
to further discuss with your plastic
surgeon, and ask questions. Give
yourself time to consider your
choices and proceed with surgery
only after you are satisfied you
understand the risks and follow-up
recommendations associated with
silicone gel-filled breast implants,
and that the decision to proceed
is the right decision for you.
You should become familiar
with and use the following
components provided in
this planner:
Section I
•B
 reast Reconstruction with
NATRELLE ® Silicone-Filled
Breast Implants
Section II — Forms
• P reoperative and Postoperative
Checklists and Instructions
• Patient Self Assessment
• Acceptance of Risk and
Surgery Consent
• Patient Surgery Record
• Device Tracking Enrollment
•O
 ptional ConfidencePlus®
Premier Warranty Enrollment Form
• Mammography Information
• To the Primary Care Physician
b re ast re co n structi o n with natrelle ®
silicone-filled breast implants
Table of Contents
Glossary.................................................................................. 1
1. Considering Silicone Gel-Filled Breast Implant Surgery.....11
1.1 What gives the breast its shape?........................................ 12
1.2 What is a silicone filled breast implant?............................... 13
1.3 Are silicone gel-filled breast implants right for you?................. 13
1.4 What important factors should you consider in
choosing silicone gel-filled implants?.................................... 15
2. Breast Implant Complications............................................ 19
2.1 What are the potential complications?................................. 19
2.2 What are other reported conditions?................................... 28
3. Allergan’s Clinical Study Results........................................ 33
3.1 What are the overview findings of Allergan’s core study?............ 33
3.2 What are the 7-year follow-up rates?................................... 34
3.3 What are the benefits?..................................................... 34
3.4 What are the 7-year complication rates?.............................. 36
3.5 What are the main reasons for reoperation?......................... 38
3.6 What are the main reasons for implant removal?.................... 40
3.7 What are other clinical data findings?................................. 41
4. Surgical Considerations For Breast Reconstruction............ 45
4.1 Should you have primary breast reconstruction?..................... 45
4.2 What are the options in primary breast reconstruction?............ 46
4.3 What are the choices in primary reconstructive procedures?......... 46
4.4 What is breast reconstruction with breast implants?................. 47
4.5 What reconstruction incision sites are used?.......................... 48
4.6 What about the surgical settings and anesthesia?................... 48
4.7 What is the timing of primary breast implant reconstruction?......... 48
4.8 What is the primary breast implant reconstruction procedure?....... 49
4.9 What about primary breast reconstruction
without implants (tissue flap procedures)?.............................. 51
4.10 What are some general surgical considerations?.................... 54
5. Follow-Up Examinations................................................... 59
6. Additional Information...................................................... 61
6.1 What types of NATRELLE ® silicone filled breast
implants are available from Allergan?.................................. 61
6.2 What if I experience a problem?........................................ 62
6.3 What is device tracking?.................................................. 63
6.4 What are the ConfidencePlus® limited warranties?.................. 64
6.5 How can I receive more information?................................... 64
For Further Reading and Information................................. 67
Index ...............................................................................72
Glossary
Glossary
Note: A glossary word appears in bold the first time it occurs in the text
of this brochure.

Areola The pigmented or darker colored area of skin

surrounding the nipple of the breast.

Asymmetry Lack of proportion of shape, size, and/or

position between the two breasts.

Atrophy Thinning or diminishing of tissues or muscle.

Autoimmune disease A disease in which the body mounts an “attack”

response to its own tissues or cell types.
Normally, the body’s immune mechanism is able
to distinguish clearly between what is a normal
substance and what is foreign. In autoimmune
diseases, this system becomes defective and
mounts an attack against normal parts of the
body, causing tissue injury. Certain diseases
such as rheumatoid arthritis, lupus,
and scleroderma are considered to be
autoimmune diseases.

Axillary Pertaining to the armpit area.

Biocompatible The condition of being compatible with living

tissues or systems without being toxic.

Biopsy The removal and examination of tissues, cells,

or fluid from the body.

Body Esteem Scale A questionnaire which asks about a person’s

body image.

Breast augmentation A surgical procedure to increase breast size.

For this document, it refers to placement of a
breast implant.

Breast implant An internal artificial device or implant intended

to replace the breast.

Breast mass A lump in the breast.

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Breast reconstruction A surgical procedure to replace breast tissue
that has been removed due to cancer or trauma
or that has failed to develop properly due to a
severe breast abnormality. For this document, it
refers to placement of a breast implant. The first
time a breast implant is placed, it is called primary
reconstruction. All subsequent times the implant is
replaced, it is called revision-reconstruction.

Calcification Process of hardening by calcium salts.

Capsular contracture A tightening of the tissue capsule surrounding an

implant, resulting in firmness or hardening of the
breast and in squeezing of the implant if severe.
Capsular contracture is classified by Baker
Grades. Baker Grades III or IV are the most
severe. Baker Grade III often results in the need
for additional surgery (reoperation) because
of pain and possible abnormal appearance.
Baker Grade IV usually results in the need for
additional surgery (reoperation) because of
pain and unacceptable appearance. Capsular
contracture Baker Grades II may also result
in the need for additional surgery. Capsular
contracture is a risk for implant rupture. Below is
a description of each Baker Grade.

Baker Grade I: Normally soft and natural

appearance
Baker Grade II: A little firm, but breast
looks normal
Baker Grade III: More firm than normal, and looks
abnormal (change in shape)
Baker Grade IV: Hard, obvious distortion, and
tenderness with pain

Capsule Scar tissue which forms around the breast

implant. Sometimes this capsule squeezes the
implant, resulting in capsular contracture.

Capsulectomy Surgical removal of the scar tissue capsule

around the implant.

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Capsulotomy (closed) An attempt to break the scar tissue capsule
around the implant by pressing or pushing on
the outside of the breast. This method does not
require surgery but is a known risk for rupture of
the implant and is contraindicated.

Capsulotomy (open) An attempt to break the scar tissue capsule

around the implant by surgical incision into
the capsule.

Congenital An abnormal development in part of the body,

abnormality present in some form since birth.

Connective tissue A disease, group of diseases, or conditions

disease/disorder (CTD) affecting connective tissue, such as muscles,
ligaments, skin, etc., and/or the immune system.
Connective tissue diseases (“CTDs”)
that involve the immune system include
autoimmune diseases such as rheumatoid
arthritis, lupus, and scleroderma.

Contraindication A use that is improper and should not be

followed. Failure to heed contraindications
identified in the labeling could cause
serious harm.

Contralateral Opposite side.

Core Study The primary clinical study of augmentation,

reconstruction, and revision (revision-
augmentation and revision-reconstruction)
patients that supported the approval of the
premarket approval (PMA) application. Safety
and effectiveness data are collected yearly
through 10 years, with the follow-up from years
5 through 10 being performed as part of a
postapproval Core Study.

Delayed Delayed progress in the healing of an

wound healing opened wound.

Diffusion Movement from one location to another.

3
Displacement Movement of the implant from the usual or
proper place.

Dysmorphic disorder A psychological condition characterized by

an obsession with a minor or an imagined
physical flaw to the point that it can interfere
with normal functioning.

Epidemiological Relating to the science of explaining the

relationships of factors that determine disease
frequency and distribution.

Extracapsular rupture A type of rupture in which the silicone gel is

outside of the scar tissue capsule surrounding
the implant.

Extrusion Skin breakdown with the pressing out of the

implant through the surgical wound or skin.

Fibromyalgia A disorder characterized by chronic pain in the

muscles and soft tissues surrounding joints, with
tenderness at specific sites in the body. It is often
accompanied by fatigue.

Fibrous tissues Connective tissues composed mostly of fibers.

Flap A portion of tissue (which may include muscle,

fat, and skin) moved from one part of the body
to another. The tissue flap may or may not have
its blood supply attached.

Granuloma A lump or mass made of inflammatory cells

surrounding a foreign substance due to
longstanding inflammation.

Hematoma A collection of blood within a space.

Hypertrophic scarring An enlarged scar remaining after the healing of

a wound.

Immune response A bodily response to the presence of a

foreign substance.

4
Infection Invasion with microorganisms (for example,
bacteria, viruses). An infection usually results in
fever, swelling, redness, and/or pain.

Inflammation The response of the body to infection or injury

that is characterized by redness, swelling,
warmth, pain, and/or loss of function.

Inframammary Below the breast.

Inframammary fold The crease at the base of the breast.

Inframammary incision An incision made in the fold below the breast.

Inpatient surgery A surgical procedure in which the patient is

required to stay overnight in the hospital.

Intracapsular rupture A type of rupture in which the silicone

gel remains inside the scar tissue capsule
surrounding the implant.

Lactation The production and secretion of milk by the

breast glands.

Latissimus dorsi Two triangular muscles running from the spinal

column to the shoulder.

Low molecular Small silicone molecules that might leak out of

weight silicones the implant.

Lymphadenopathy Enlargement of the lymph node(s).

Lymphedema Swelling of the lymph nodes.

MRI Magnetic resonance imaging. A radiographic

examination that currently has the best ability
to detect rupture of silicone gel-filled
breast implants.

Malposition Implant malposition or displacement is when the

implant is not in the correct spot in the breast.
This could have been due to incorrect placement
of the implant during the surgery or due to
shifting of the implant position over time.

5
Mammary Pertaining to the breast.

Mammography A type of X-ray examination of the breasts used

for detection of cancer.

Screening mammography – x-ray examination

of the breast that is performed on women with
no complaints or symptoms of breast cancer; the
goal is to detect breast cancer when it is still too
small to be felt by a physician or the patient.

Diagnostic mammography – x-ray examination

in order to evaluate a breast complaint or
abnormality detected by physical exam or
screening mammography; additional views of
the breast are usually taken.

Mammoplasty Plastic surgery of the breast.

Mastectomy The removal of breast tissue due to the presence

of a cancerous or precancerous growth.

• Subcutaneous mastectomy: surgical removal
of the breast tissues, but sparing the skin,
nipple, and areola.

• Total mastectomy: surgical removal of the
breast including the nipple, areola, and most
of the overlying skin.

• Modified radical mastectomy: surgical
removal of the entire breast including the
nipple, areola, and overlying skin, as well as
the lymphatic-bearing tissue in the axilla.

• Radical mastectomy: surgical removal of the
entire breast including the nipple, areola, and
overlying skin, as well as the pectoral muscles,
lymphatic-bearing tissue in the axilla, and
various other neighboring tissue.

Mastitis Inflammation of the breast.

Mastopexy Plastic surgery to lift sagging breasts higher.

6
Metastatic Disease Spreading of cancer cells from the original site
to other parts of the body.

Migration Movement of silicone materials outside the

breast implant.

Necrosis Death of cells or tissues.

Oncologist A doctor who studies, identifies, and treats cancer.

Outpatient surgery A surgical procedure in which the patient is not

required to stay in the hospital overnight.

Palpability The ability to feel the implant.

Palpate/palpable To feel with the hand.

Paresthesis The feelings of pins and needles in a particular

area of your body (particularly the arms and legs).

Pectoralis Major muscle of the chest.

Periareolar Around the darkened or pigmented area

surrounding the nipple of the breast.

Plastic surgery Surgery intended for the improvement of

appearance of the body.

Postoperatively After surgery.

Primary breast The first time a breast implant is placed for the
reconstruction purpose of breast reconstruction.

Ptosis Breast sagging that is usually the result of normal

aging, pregnancy, or weight loss.

Reoperation An additional surgery after your first

breast implantation.

Revision-reconstruction Refers to the correction or improvement of

a primary reconstruction. In the context
of this document, it refers to surgical removal
and replacement of breast implants that
were placed originally for primary
breast reconstruction.

7
Rheumatological A variety of diseases involving connective tissue
disease/disorder structures of the body, especially the joints
and fibrous tissue. These diseases are often
associated with pain, inflammation, stiffness,
and/or limitation of motion of the affected parts.
Can include autoimmune diseases. Fibromyalgia
is a rheumatological disorder.

Rosenberg A 10-item questionnaire intended to measure

Self-Esteem Scale overall self-esteem through statements related to
feelings of self-worth and self-acceptance.

Rupture A tear or hole in the implant shell. Silicone

implant ruptures may be with or without
symptoms. Ruptures can be intracapsular
or extracapsular.

Saline A solution that is made up of water and a small

amount of salt.

Scar revision A surgical procedure to improve the appearance

of a scar.

Seroma A build-up of the watery portion of the blood in

a tissue location.

SF-36 Scale A 36-item questionnaire intended to measure

patient health in areas such as vitality,
physical functioning, bodily pain, general
health, social and emotional functioning,
and mental health.

Silent rupture A breast implant rupture without symptoms

and which is not apparent except through
appropriate imaging techniques such as MRI.
Most silicone gel-filled breast implant ruptures
are silent (see symptomatic rupture below).

Silicone elastomer A type of silicone that has elastic properties

similar to rubber.

8
Subglandular Placement of a breast implant underneath
placement and within the breast glands but on top of
the chest muscle.

Submuscular Placement of a breast implant wholly or partially

underneath the chest muscle.

Surgical incision A cut made to body tissue during surgery.

Symptom Any perceptible change in the body or its

functions that indicates disease or a phase
of a disease.

Symptomatic Any evidence or sign of disease or disorder

reported by the patient.

Symptomatic A breast implant rupture that is associated with

rupture symptoms (such as lumps, persistent pain,
swelling, hardening, or change in implant
shape). Some silicone gel-filled breast implant
ruptures are symptomatic, but most are silent.

Systemic Pertaining to or affecting the body as a whole.

Tennessee A questionnaire intended to measure the

Self-Concept Scale patient’s view of her body and state of health,
as well as her attitude about appearance, skills,
and sexuality. The questionnaire administered in
the Core Study consisted of 18 items.

Toxic shock Infection from staphylococci, occurring most

syndrome often in the vagina of menstruating women
using superabsorbent tampons but can also
occur in other soft tissue infections. Symptoms
include high fever, vomiting, diarrhea, rash,
decreased blood pressure and shock, which
can result in death.

Transaxillary Through the axilla (armpit); an incision made

under the arm.

9
10
1. Considering
Surgery
1. CONSIDERING SILICONE
GEL-FILLED BREAST
IMPLANT SURGERY
You may be considering breast implant surgery to restore your
breast shape after a mastectomy or an injury that resulted in
either partial or total loss of the breast(s) or to correct a birth
defect. This is referred to as breast reconstruction. Or you
may need revision of a previous breast reconstruction, which
is called revision-reconstruction. Whether you decide to have
breast reconstruction depends on your own individual case,
medical condition, general health, lifestyle, emotional state,
and breast size and shape. You may wish to speak with your
family, friends, breast implant support groups, and breast
cancer support groups to help you in making this decision.
If you are considering breast reconstruction and do not have
a plastic surgeon, ask your general surgeon for the names of
experienced, board-certified plastic surgeons in your area.
Your general surgeon, plastic surgeon, and oncologist should
work together to plan your mastectomy and reconstruction
procedure to give you the best possible result.
Allergan has prepared this information to help you better
understand the breast implant procedure and assist you in
making an informed decision about breast reconstruction or
revision-reconstruction surgery. It will help to answer some
of the questions you may have about the surgery and about
breast implants in general. It will also provide you with
specific information about the risks and benefits of NATRELLE®
Silicone-Filled Breast Implants.
This information cannot and should not replace discussing
your surgery with your plastic surgeon. Your decision whether
or not to get breast implants should be based on realistic
expectations of the outcome. There is no guarantee that
your results will match those of other women. Your results
will depend on many individual factors, such as your overall
health (including age), chest structure, breast/nipple shape
and position, skin texture, healing capabilities (which may be
slowed by radiation and chemotherapy treatment, smoking,

11
alcohol, and various medications), tendency to bleed, prior
breast surgery, surgical team’s skill and experience, type of
surgical procedure, and type and size of implant. Make sure
you speak with your surgeon about your expectations of the
results, as well as what you can expect regarding the length
of the surgery, your recovery, and any risks and potential
complications of the surgery. Ask questions.
As part of your decision, both you and your surgeon will be
required to sign Allergan’s consent to surgery form that confirms
your understanding of what you have read. This Allergan
consent document will be provided to you by your surgeon.
You should wait at least 1-2 weeks after reviewing and
considering this information before deciding whether to
have primary breast reconstruction surgery. In the case of
a revision-reconstruction, however, your surgeon may find it
medically necessary to perform surgery sooner.

1.1 What Gives the Breast Its Shape?

The breast consists of milk ducts and glands, surrounded by
fatty tissue that provides its shape and feel. Beneath the breast
is the chest muscle (pectoralis major muscle).

Fat ty tissue

ribs

pectoralis muscles

mil k ducts
and glands

Factors such as pregnancy (when milk glands are temporarily

enlarged), rapid weight loss, and the effects of gravity as
you age combine to stretch the skin, which may cause the
breast to droop or sag. However, it is important to realize

12
that implants are used to make the breast larger or to restore/
replace breast tissue. The implants alone may not adequately
lift the breast, or correct the effects of pregnancy, weight
loss, or skin stretching. Your surgeon may suggest additional
procedures at the time of the breast reconstruction, such as
mastopexy, to help achieve improved breast lift.
Breast cancer surgery can significantly change the shape of
the breast, to a greater or lesser degree, depending on a
number of factors. These factors include how much breast
tissue is removed in a partial or complete mastectomy; how
much skin is removed at the time of surgery; and how much
tissue reaction or scarring there is in the remaining breast and
skin in response to chemotherapy or radiation therapy.

1.2 What is a Silicone Filled

Breast Implant?

A silicone gel-filled breast implant is a sac (implant shell)

of silicone elastomer (rubber) filled with silicone gel. It is
surgically implanted either under your breast tissue or under
your chest muscle.

1.3 Are Silicone Gel-Filled Breast

Implants Right For You?
NATRELLE ® Silicone-Filled Breast Implants are indicated for
females for the following uses (procedures):

13
• Breast augmentation for women at least 22 years old.
Breast augmentation includes primary breast
augmentation to increase the breast size, as well as
revision surgery to correct or improve the result of a
primary breast augmentation surgery. (A separate patient
brochure is available for those women considering breast
augmentation surgery and should be read prior to
reaching a decision to undergo breast augmentation).
• Breast reconstruction. Breast reconstruction includes
primary reconstruction to replace breast tissue that has
been removed due to cancer or trauma or that has failed
to develop properly due to a severe breast abnormality.
Breast reconstruction also includes revision surgery to
correct or improve the result of a primary breast
reconstruction surgery.
Contraindications

Breast implant surgery should not be performed in:

• Women with active infection anywhere in their body.
• Women with existing cancer or pre-cancer of their
breast who have not received adequate treatment for
those conditions.
• Women who are currently pregnant or nursing.
Precautions

Safety and effectiveness have not been established in patients

with the following:
• Autoimmune diseases (for example, lupus and
scleroderma).
• A weakened immune system (for example, currently
taking drugs that weaken the body’s natural resistance
to disease).
• Conditions that interfere with wound healing and
blood clotting.
• Reduced blood supply to breast tissue.
• Radiation to the breast following implantation.

14
 • Clinical diagnosis of depression or other mental health
disorders, including body dysmorphic disorder and
eating disorders. Please discuss any history of mental
health disorders with your surgeon prior to surgery.
Patients with a diagnosis of depression, or other
mental health disorders, should wait until resolution or
stabilization of these conditions prior to undergoing
breast implantation surgery.

1.4 What Important Factors Should

You Consider In Choosing Silicone
Gel-Filled Implants?
• You should be aware that there are many factors that
will affect the outcome and timing of your
reconstruction with breast implants, such as the stage
of your disease, the type and extent of cancer removal
surgery you have had, the amount of skin and soft
tissue available for the reconstruction, and additional
treatments such as chemotherapy and radiation, which
you may require.
Breast implants are not lifetime devices,
• 
and breast implantation is likely not a
one-time surgery. You will likely need additional
unplanned surgeries on your reconstructed and/
or contralateral augmented breasts because of
complications or unacceptable cosmetic outcomes.
These additional surgeries can include implant removal
with or without replacement, or they can include
other surgical procedures. When you have your
implants replaced (revision-reconstruction), your risk of
future complications increases compared to first time
(primary) reconstruction surgery, so you should also
review the complication rates for revision-reconstruc-
tion patients to see what future risk rates you may
experience.

15
 • Many of the changes to your breast following
implantation are irreversible (cannot be undone).
If you later choose to have your implant(s) removed
and not replaced, you may experience unacceptable
dimpling, puckering, wrinkling, or other cosmetic
changes of the breast, which can be permanent.
• If you undergo a mastectomy, removal of the breast
tissue eliminates the ability to breastfeed with the
removed breast. In addition, contralateral breast
augmentation may affect your ability to breastfeed,
by either reducing or eliminating milk production.
• Rupture of a silicone gel-filled breast implant is most
often without symptoms (silent). This means that most
of the time neither you nor your surgeon will know that
your implants have a rupture. In fact, the ability of a
physical examination by a plastic surgeon who is
familiar with breast implants to detect silicone breast
implant rupture is 30%3 compared to 89% for MRI.4
You will need regular screening MRI examinations over
your lifetime in order to determine if silent rupture is
present. You should have your first MRI at 3 years after
your initial implant surgery and then every 2 years,
thereafter. The cost of MRI screenings may exceed the
cost of your initial surgery over your lifetime. This
cost, which may not be covered by your insurance,
should be considered in making your decision.
• If implant rupture is noted on MRI, you should have
the implant removed, with or without replacement.
• With breast implants, routine screening
mammography for breast cancer will be more
difficult. If you are of the proper age for
mammography screening, you should continue to
undergo routine mammography screening as
recommended by your primary care physician. The
implant may interfere with finding breast cancer
during mammography. Because the breast and implant
are squeezed during mammography, an implant may
rupture during the procedure. More x-ray views are

16
 necessary for women with breast implants; therefore,
you will receive more exposure to radiation.
However, the benefit of having the mammogram to
find cancer outweighs the risk of the additional x-rays.
Be sure to inform the mammography technologist that
you have implants.
• You should perform an examination of your breasts
every month for cancer screening; however, this may
be more difficult with implants. You should ask your
surgeon to help you distinguish the implant from your
breast tissue.
• You should perform an examination of your breasts for
the presence of lumps, swelling, hardening, or change
in implant shape, which may be signs of symptomatic
rupture of the implant. Report any of these symptoms
or persistent pain to your surgeon. Your surgeon may
recommend an evaluation via MRI to screen
for rupture.
• The timing for any revision following reconstruction
surgery should be discussed with your surgeon so that
all issues such as the potential effects of radiation,
chemotherapy, and additional cancer surgery or
treatments can be fully discussed.
• After undergoing cancer treatment and/or
reconstructive breast surgery (either primary or
revision), your health insurance premiums may
increase, your insurance coverage may be dropped,
and/or future coverage may be denied. Treatment of
complications may not be covered as well. You should
discuss the complete extent of your insurance coverage
with your insurance company before undergoing
reconstructive surgery with breast implants.
• You should inform any other doctor who treats you of
the presence of your implants to minimize the risk of
damage to the implants.
• Allergan will continue its ongoing clinical Core Study
through 10 years to further evaluate the long-term

17
 safety and effectiveness of these products. In addition,
Allergan has initiated a separate, 10-year
postapproval study (the Breast Implant Follow-Up
Study, or BIFS) to address specific issues for which the
Allergan Core Study was not designed to fully answer,
as well as to provide a real-world assessment of some
endpoints. The endpoints in the large postapproval
study include long-term local complications,
connective tissue disease (CTD), CTD signs and
symptoms, neurological disease, neurological signs
and symptoms, offspring issues, reproductive issues,
lactation issues, cancer, suicide, mammography
issues, and MRI compliance and results. Allergan
will update its labeling on a regular basis with the
results of these two studies. You should also ask your
surgeon for any available updated Allergan
clinical information.
• It is important that you read this entire brochure
because you need to understand the risks and benefits
and to have realistic expectations of the outcome of
your surgery.

18
2. Complications
2. BREAST IMPLANT COMPLICATIONS
Undergoing any type of surgical procedure involves risks
(some serious) such as the effects of anesthesia, infection,
swelling, redness, bleeding, pain, and even death, which
need to be balanced against the benefits of the surgery itself.
There are potential complications specific to breast implant
surgery and breast implants, as described below. Located
at the end of this brochure is a list of published studies used
to gather the information discussed in the sections below.
These may be helpful to you if you wish to learn more about
a specific complication or condition. The reference list is
not complete because studies are being conducted all the
time; your physician may have other resources for further
reading as well. It should be noted that the references
include augmentation and/or reconstruction patients,
as well as implants of different types and from a variety
of manufacturers.

2.1 What Are the Potential Complications?

• Rupture
Breast implants are not lifetime devices. Breast implants
rupture when the shell develops a tear or hole. Ruptures can
occur at any time after implantation, but they are more likely
to occur the longer the implant is implanted. The following
things may cause your implant to rupture: damage by surgical
instruments; stressing the implant during implantation which
may weaken it; folding or wrinkling of the implant shell;
excessive force to the chest (for example, during closed
capsulotomy, which is contraindicated); trauma; compression
during mammographic imaging; and severe capsular
contracture. Breast implants may also simply wear out over
time. Laboratory studies have identified some of the types
of rupture for Allergan’s product; however, it is not known
whether these tests have identified all causes of rupture. These
laboratory studies will continue postapproval.
Silicone gel-filled breast implant ruptures are most often silent.
(MRI examination is currently the best method to screen for
silent rupture.) This means that most of the time neither you nor
your plastic surgeon will know if the implant has a tear

19
or hole in the shell. This is why MRI is recommended at 3
years and then every 2 years, thereafter, to screen for rupture.
However, sometimes there are symptoms associated with
gel implant rupture. These symptoms include hard knots or
lumps surrounding the implant or in the armpit, change or
loss of size or shape of the breast or implant, pain, tingling,
swelling, numbness, burning, or hardening of the breast.
When MRI signs of rupture are found, or if your surgeon
determines you have signs or symptoms of rupture, you should
have the implant and any gel removed, with or without
replacement of the implant. It also may be necessary to
remove the tissue capsule as well as the implant, which will
involve additional surgery, with associated costs. If you have
symptoms such as breast hardness, a change in breast shape
or size, and/or breast pain, you should have an MRI to
determine whether rupture is present. 1,5
There are also consequences of rupture. If rupture occurs,
silicone gel may either remain within the scar tissue capsule
surrounding the implant (intracapsular rupture), move outside
the capsule (extracapsular rupture), or gel may move beyond
the breast (gel migration). There is also a possibility that
rupture may progress from intracapsular to extracapsular and
beyond. There have also been health consequences reported
in the literature. See below for details.
Rupture Information on Allergan Implants
In Allergan’s Core Study, rupture was assessed for patients
who had scheduled MRIs to screen for silent rupture (i.e.,
part of the MRI cohort) and those who were not assessed for
rupture by MRI (i.e., part of the non-MRI cohort). For primary
reconstruction patients in the MRI cohort, the by-patient rupture
rate was 11.4% and the by-implant rupture rate was 9.3%
through 7 years. For revision-reconstruction patients in the MRI
cohort, the rupture rate was 0% through 7 years. This means
that through 7 years, approximately 11 of every 100 primary
reconstruction women had at least one ruptured breast implant.
There were no revision-reconstruction patients with a ruptured
breast implant. No ruptures were reported in the non-MRI
primary reconstruction and revision-reconstruction cohorts.

20
The rupture rate for the whole MRI cohort in the Core
Study (including augmentation, revision-augmentation,
reconstruction, and revision-reconstruction patients) through
7 years was 7.3% for patients and 4.5% for implants. Across
all patients in the Allergan Core Study, all ruptures were
intracapsular with 1 case of extracapsular gel (one rupture
progressed to extracapsular gel following exploratory surgery
to confirm the rupture and then implant replacement was
delayed). There were no cases of migrated gel.
Further rupture rate information on NATRELLE ® Silicone-Filled
Breast Implants is provided from a published European
study known as the International MRI Study.2 Silent rupture
data were collected via a single MRI on 77 augmentation,
11 reconstruction, and 18 revision patients implanted with
smooth and textured NATRELLE ® implants by five surgeons.
The average age of the implants was approximately 11
years. Silent rupture was found in approximately 15% of the
combined group of augmentation, reconstruction, and revision
patients and 8% of the implants. There was one possible
case of extracapsular rupture with the remainder classified as
intracapsular ruptures. No cases of gel migration were found.
Additional information on rupture will be collected through
Allergan’s postapproval studies: the continuing Core Study
and Breast Implant Follow-Up Study (BIFS).
Additional Information on Consequences of Rupture
from Literature
Since silicone implants were not available in the United
States for many years but were used in Europe during that
time, some information on rupture rates comes from studies
conducted in Europe. Studies of Danish women evaluated
with MRI involving a variety of manufacturers and implant
models showed that about three-fourths of implant ruptures are
intracapsular and the remaining one-fourth are extracapsular.6
Additional studies of Danish women indicate that over a
2-year period, about 10% of the implants with intracapsular
rupture progressed to extracapsular rupture as detected by
MRI.5 This means that for women with silicone gel rupture
within the scar tissue capsule detected via MRI after 2 years,
1 in 10 of these women had progression of the gel

21
outside the scar tissue capsule. In about half of these cases
of progression from intracapsular to extracapsular rupture, the
women had had trauma or mammography. In the other half,
no cause was given. In the women with extracapsular rupture,
after 2 years, the amount of silicone outside the scar tissue
capsule increased for about 14% of these women. This means
that for 100 women with silicone gel rupture outside the
scar tissue capsule, the amount of gel outside the scar tissue
capsule increased for 14 women 2 years later. This type of
information pertains to a variety of silicone implants from a
variety of manufacturers and implant models, and it is not
specific to Allergan implants.
Below is a summary of information related to the health
consequences of implant rupture, which have not been fully
established. These reports were in women who had implants
from a variety of manufacturers and implant models.
• Local breast complications reported in the published
literature which were associated with rupture include
breast hardness, a change in breast shape or size,
and breast pain.5 These symptoms are not specific to
rupture, as they also are experienced by women who
have capsular contracture.
• There have been rare reports of gel movement
to nearby tissues such as the chest wall, armpit,
or upper abdominal wall, and to more distant
locations down the arm or into the groin. This has
led to nerve damage, granuloma formation and/
or breakdown of tissues in direct contact with the gel
in a few cases.There have been reports of silicone
presence in the liver of patients with silicone breast
implants. Movement of silicone gel material to lymph
nodes in the axilla also has been reported, even
in women without evidence of rupture, leading to
lymphadenopathy.43
• Concerns have been raised over whether ruptured
implants are associated with the development of
connective tissue or rheumatic diseases and/or
symptoms such as fatigue and fibromyalgia.11,12,18,19

22
 A number of epidemiology studies have evaluated
large populations of women with breast implants.
These studies do not, taken together, support a
significant association of breast implants with a
typical, diagnosed rheumatic disease. Other than one
small study,12 these studies do not distinguish whether
the women had ruptured or intact implants.
• Capsular Contracture
The scar tissue (capsule) that normally forms around the
implant may tighten over time and compress the implant,
making it feel firm and leading to what is called capsular
contracture. Capsular contracture may be more common
following infection, hematoma, and seroma, and the chance
of it happening may increase over time. Capsular contracture
occurs more commonly in revision-reconstruction than in
primary reconstruction. Because you may have your initial
implants replaced, you should be aware that your risk of
capsular contracture increases with revision-reconstruction.
Capsular contracture is a risk factor for implant rupture, and it
is one of the most common reasons for reoperation.
Symptoms of capsular contracture range from mild firmness
and mild discomfort to severe pain, distorted shape of the
implant, and palpability (ability to feel the implant). Capsular
contracture is graded into 4 levels depending on its severity.*
Baker Grades III and IV are considered severe, and often
additional surgery is needed to correct these grades.
Baker Grade I: the breast is normally soft and looks natural
Baker Grade II: the breast is a little firm but looks normal
Baker Grade III: the breast is firm and looks abnormal
Baker Grade IV: the breast is hard, painful, and looks abnormal
In Allergan’s Core Study, for women receiving reconstruction
implants for the first time, the risk of severe capsular contracture
was 17% through 7 years. This means that 17 out of every
100 women who received Allergan implants for primary breast
reconstruction had severe capsular contracture at least once
during the first 7 years after receiving the implants.
* Baker, J.L. Augmentation mammaplasty. In: Owsley, J.Q. and Peterson, R.,
Eds. Symposium on aesthetic surgery of the breast. St. Louis, MO: Mosby;
1978:256-263.

23
For women receiving revision-reconstruction implants, the risk
of severe capsular contracture was 7% through 7 years.
Additional surgery may be needed in cases where pain and/
or firmness are severe. This surgery ranges from removal
of the implant capsule tissue to removal and possible
replacement of the implant itself. This surgery may result in
loss of your breast tissue. Capsular contracture may happen
again after these additional surgeries. Capsular contracture
may increase the risk of rupture.1
• Additional Surgeries (Reoperations)
You should assume that you will need to have additional
surgeries (reoperations). In Allergan’s Core Study, the reoperation
rate was 53% for primary reconstruction patients, and 40%
for revision-reconstruction patients, which means that 53 out of
every 100 women who received Allergan implants for primary
reconstruction and 40 out of every 100 women who received
Allergan implants for revision-reconstruction had a reoperation
during the first 7 years after receiving the implants.
Patients may decide to change the size or type of their
implants, requiring additional surgery. In addition, problems
such as rupture, capsular contracture, hypertrophic scarring
(irregular, raised scar), asymmetry, infection, and shifting can
require additional surgery. Tables 3 and 4, which summarize
the main reasons for performing reoperations in the Core
Study, are located in section 3.5. For women receiving
primary reconstruction implants, the three most common
reasons for reoperation were implant malposition, asymmetry,
and capsular contracture. For women receiving revision-
reconstruction implants, the most common reason reported for
reoperation was nipple complications.
• Implant Removal
Because these are not lifetime devices, the longer you have
your implants the more likely it will be for you to have them
removed for any reason, either because of dissatisfaction, an
unacceptable cosmetic result, or a complication such as capsular
contracture. Having your implants removed and replaced
increases your chances of getting future complications.
For women receiving primary reconstruction implants in

24
Allergan’s Core Study, 30% had their implants removed at
least once through 7 years. Implant malposition, asymmetry,
and capsular contracture were the most common reasons for
implant removal. One woman receiving revision-reconstruction
implants in Allergan’s Core Study had an implant removed
through 7 years. The reason for removal was asymmetry.
Most women who have their implants removed have them
replaced with new implants, but some women do not. If
you choose not to replace your implants, you may have
cosmetically unacceptable dimpling, puckering, wrinkling,
and/or other potentially permanent cosmetic changes of the
breast following removal of the implant. Even if you have your
implants replaced, implant removal may result in loss of your
breast tissue. Also, implant replacement increases your risks
of future complications. For example, the risks of capsular
contracture and reoperation increase for patients with implant
replacement compared to first time placement. You should
consider the possibility of having your implants replaced and its
consequences when making your decision to have implants.
• Unsatisfactory Results
Unsatisfactory results such as wrinkling, asymmetry, implant
displacement (shifting), incorrect size, unanticipated shape,
implant palpability, scar deformity, and/or hypertrophic
scarring, may occur. Some of these results may cause
discomfort. Pre-existing asymmetry may not be entirely
correctable by implant surgery. Revision surgery may be
recommended to maintain patient satisfaction, but carries
additional considerations and risks. Selecting an experienced
plastic surgeon may minimize, but not necessarily prevent,
unsatisfactory results.
• Pain
Pain of varying intensity and length of time may occur and
persist following breast implant surgery. In addition, improper
size, placement, surgical technique, or capsular contracture
may result in pain. You should tell your surgeon about
significant pain or if your pain persists.

25
• Changes in Nipple and Breast Sensation
Feeling in the nipple and breast can increase or decrease
after implant surgery. The range of changes varies from
intense sensitivity to no feeling in the nipple or breast
following surgery. While some of these changes can be
temporary, they can also be permanent, and may affect
your sexual response or your ability to nurse a baby. (See
paragraph on breastfeeding below).
• Infection
Infection can occur with any surgery or implant. Most
infections resulting from surgery appear within a few days
to weeks after the operation. However, infection is possible
at any time after surgery. In addition, breast and nipple
piercing procedures may increase the possibility of infection.
Infections in tissue with an implant present are harder to treat
than infections in tissue without an implant. If an infection
does not respond to antibiotics, the implant may have to
be removed, and another implant may be placed after the
infection is resolved (cleared up). As with many other surgical
procedures, in rare instances, toxic shock syndrome has
been noted in women after breast implant surgery, and it is
a life-threatening condition. Symptoms include sudden fever,
vomiting, diarrhea, fainting, dizziness, and/or sunburn-like
rash. You should contact a doctor immediately for diagnosis
and treatment if you have these symptoms.
• Hematoma/Seroma
Hematoma is a collection of blood within the space around
the implant, and a seroma is a build-up of fluid around the
implant. Having a hematoma and/or seroma following
surgery may result in infection and/or capsular contracture
later on. Symptoms from a hematoma or seroma may include
swelling, pain, and bruising. If a hematoma or seroma
occurs, it will usually be soon after surgery. However, this
can also occur at any time after injury to the breast. While
the body absorbs small hematomas and seromas, some will
require surgery, typically involving draining and potentially
placing a surgical drain in the wound temporarily for proper
healing. A small scar can result from surgical draining.
Implant rupture also can occur from surgical draining if there
is damage to the implant during the draining procedure.

26
• Breastfeeding
Breastfeeding difficulties have been reported following breast
surgery, including breast reduction and breast reconstruction.
If your surgeon uses a periareolar surgical approach (an
incision around the colored portion surrounding the nipple), it
may further increase the chance of breastfeeding difficulties.
• Calcium Deposits in the Tissue Around the Implant
Calcium deposits can form in the tissue capsule surrounding
the implant. Symptoms may include pain and firmness.
Deposits of calcium can be seen on mammograms and
can be mistaken for possible cancer, resulting in additional
surgery for biopsy and/or removal of the implant to
distinguish calcium deposits from cancer. If additional surgery
is necessary to examine and/or remove calcifications, this
may cause damage to the implants. Calcium deposits also
occur in women who undergo breast reduction procedures,
in patients who have had hematoma formation, and even
in the breasts of women who have not undergone any
breast surgery. The occurrence of calcium deposits increases
significantly with age.
• Extrusion
Extrusion is when the breast implant comes through your
skin. This may occur, for example, when your wound has
not closed or when breast tissue covering your implants
weakens. Radiation therapy has been reported to increase
the likelihood of extrusion. Extrusion requires additional
surgery and possible removal of the implant, which may result
in additional scarring and/or loss of your breast tissue.
• Necrosis
Necrosis is the death of cells or tissues. This may prevent or
delay wound healing and require surgical correction, which
may result in additional scarring and/or loss of your breast
tissue. Implant removal may also be necessary. Factors
associated with increased necrosis include infection, use of
steroids, smoking, chemotherapy/radiation, and excessive
heat or cold therapy.

27
• Delayed Wound Healing
Some patients may experience a prolonged wound healing
time. Delayed wound healing may increase the risk of
infection, extrusion, and necrosis. Depending on the type
of surgery or the incision, wound healing times may vary.
Smoking may interfere with the healing process. You should
contact your surgeon immediately if your wound does not heal
within the period of time he/she has discussed with you.
• Breast Tissue Atrophy/Chest Wall Deformity
The pressure of the breast implant may cause breast tissue
thinning (with increased implant visibility and palpability) and
chest wall deformity. This can occur while implants are still
in place or following implant removal without replacement.
Either of these conditions may result in additional surgeries
and/or unacceptable dimpling/puckering of the breast.
• Lymphadenopathy
Lymphadenopathy is a chronic enlargement of the lymph
nodes. A lymph node is a round mass of tissue which makes
cells as part of your immune system. The lymph nodes in
the armpit (axilla) drain the breast area of fluid. Sometimes
the enlarged lymph nodes are painful. If they become too
large or painful, the lymph node(s) may need to be surgically
removed. Painful and/or enlarged lymph nodes should be
reported to your doctor.
Literature reports associate lymphadenopathy with both
intact and ruptured silicone breast implants. One study
reported that armpit lymph nodes from women with both
intact and ruptured silicone gel implants had abnormal tissue
reactions, granulomas, and the presence of silicone.43 These
reports were in women who had implants from a variety of
manufacturers and implant models.

2.2 What Are Other Reported Conditions?

There have been reports in the literature of other conditions
in women with silicone gel-filled breast implants. Many of
these conditions have been studied to evaluate their potential
association with breast implants. Although no cause-and-effect
relationship has been established between breast implants

28
and the conditions listed below, you should be aware of
these reports. Furthermore, there is the possibility of risks,
yet unknown, which in the future could be determined to be
associated with breast implants.
• Connective Tissue Disease (CTD)
Connective tissue diseases include diseases such as lupus,
scleroderma, and rheumatoid arthritis. Fibromyalgia is a
disorder characterized by chronic pain in the muscles and
soft tissues surrounding joints, with tenderness at specific
sites in the body. It is often accompanied by fatigue. There
have been a number of published epidemiological studies
which have looked at whether having a breast implant is
associated with having a typical or defined connective
tissue disease.1,10-18 The published studies overall show
that breast implants are not significantly associated with
a risk of developing a typical or defined connective tissue
disease.1,13-15 However, the study size needed to conclusively
rule out a small risk of connective tissue disease among
women with silicone gel-filled implants would need to be
very large. These studies do not distinguish between women
with intact and ruptured implants. Only one study evaluated
specific connective tissue disease diagnoses and symptoms
in women with silent ruptured versus intact implants, but the
study was too small to rule out a small risk.12
• CTD Signs and Symptoms
Literature reports have also been made associating silicone
breast implants with various rheumatological signs and
symptoms such as fatigue, exhaustion, joint pain and
swelling, muscle pain and cramping, tingling, numbness,
weakness, and skin rashes. Scientific expert panels and
literature reports have found no evidence of a consistent
pattern of signs and symptoms in women with silicone breast
implants.1,19-22 Having these rheumatological signs and
symptoms does not necessarily mean you have a connective
tissue disease; however, you should be aware that you
may experience these signs and symptoms after undergoing
breast implantation. If you notice an increase in these signs
or symptoms, you should consider seeing a rheumatologist
to determine whether these signs or symptoms are due to a
connective tissue disorder or autoimmune disease.

29
• Cancer
Breast Cancer – Reports in the medical literature indicate
that patients with breast implants are not at a greater risk
than those without breast implants for developing breast
cancer.23,25,27,30,35 Some reports have suggested that breast
implants may interfere with or delay breast cancer detection
by mammography and/or biopsy; however, other reports
in the published medical literature indicate that breast
implants neither significantly delay breast cancer detection
nor adversely affect cancer survival of women with breast
implants.23,28,31,34,35
Brain cancer – One recent study has reported an increased
incidence of brain cancer in women with breast implants as
compared to the general population.24 The incidence of brain
cancer, however, was not significantly increased in women
with breast implants when compared to women who had
other plastic surgeries. Another recently published review of
four large studies of women with cosmetic implants concluded
that the evidence does not support an association between
brain cancer and breast implants.
Respiratory/lung cancer – One study has reported an
increased incidence of respiratory/lung cancer in women
with breast implants.24 Other studies of women in Sweden
and Denmark have found that women who get breast
implants are more likely to be current smokers than women
who get breast reduction surgery or other types of cosmetic
surgery.26,29,32
Cervical/vulvar cancer – One study has reported an
increased incidence of cervical/vulvar cancer in women with
breast implants.24 The cause of this increase is unknown.
Other cancers – One study has reported an increased
incidence of stomach cancer and leukemia in women with
breast implants compared to the general population.24 This
increase was not significant when compared to women who
had other types of plastic surgeries.
• Neurological Disease, Signs, and Symptoms
Some women with breast implants have complained of
neurological symptoms (such as difficulties with vision,

30
sensation, muscle strength, walking, balance, thinking or
remembering things) or diseases (such as multiple sclerosis),
which they believe are related to their implants. A scientific
expert panel report found that the evidence for a neurological
disease or syndrome caused by or associated with breast
implants is insufficient or flawed.1
• Suicide
In several studies, a higher incidence of suicide was observed
in women with breast implants.36-39 The reason for the
observed increase is unknown, but it was found that women
with breast implants had higher rates of hospital admission
due to psychiatric causes prior to surgery, as compared with
women who had breast reduction or in the general population
of Danish women.37
• Effects on Children
At this time, it is not known if a small amount of silicone may
pass through from the breast implant silicone shell into breast
milk during breastfeeding. Although there are no current
established methods for accurately detecting silicone levels
in breast milk, a study measuring silicon (one component in
silicone) levels did not indicate higher levels in breast milk
from women with silicone gel-filled implants when compared
to women without implants.
In addition, concerns have been raised regarding potential
damaging effects on children born to mothers with implants.
Two studies in humans have found that the risk of birth defects
overall is not increased in children born after breast implant
surgery.41,42 Although low birth weight was reported in a third
study, other factors (for example, lower pre-pregnancy weight)
may explain this finding.40 The author recommended further
research on infant health.
• Potential Health Consequences of Gel Bleed
Small quantities of low molecular weight (LMW) silicone
compounds, as well as platinum (in zero oxidation state),
have been found to diffuse (bleed) through an intact implant
shell.1,45 The evidence is mixed as to whether there are
any clinical consequences associated with gel bleed. For
instance, studies on implants implanted for a long duration

31
have suggested that such bleed may be a contributing
factor in the development of capsular contracture and
lymphadenopathy.43 However, evidence against gel bleed
being a significant contributing factor to capsular contracture
and other local complications is provided by the fact that
there are similar or lower complication rates for silicone
gel-filled breast implants than for saline-filled breast implants.
Saline-filled breast implants do not contain silicone gel
and, therefore, gel bleed is not an issue for those products.
Furthermore, toxicology testing has indicated that the silicone
material used in Allergan’s implants does not cause toxic
reactions when large amounts are administered to test
animals. It should also be noted that studies reported in the
literature have demonstrated that the low concentration of
platinum contained in breast implants is in the zero oxidation
(most biocompatible) state.44,46,47,49
Allergan performed a laboratory test to analyze the silicones
and platinum (used in the manufacturing process), which may
bleed out of intact implants into the body. Over 99% of the
LMW silicones and platinum stayed in the implant. The overall
body of available evidence supports that the extremely low
level of gel bleed is of no clinical consequence.

32
3. Clinical Study
Results
3. ALLERGAN’S CLINICAL STUDY RESULTS
This section of the brochure summarizes the results of the
Allergan Core Study conducted on NATRELLE® Silicone-Filled
Breast Implants for primary reconstruction and revision-recon-
struction. The Allergan Core Study is the primary clinical study
for this product. The results of the Core Study give you useful
information on the experience of other women with NATRELLE®
Silicone-Filled Breast Implants. While the results cannot be
used to predict your individual outcome, they can be used
as a general guide of what you may expect. Your own
complications and benefits depend on many individual factors.
As a note, supplemental safety information was also obtained
from another Allergan clinical study (the Adjunct Study),
the Danish Breast Implant Registry, an international clinical
MRI study, and the literature to help assess long-term rupture
rate and the consequences of rupture for this product. The
literature, which had the most available information on the
consequences of rupture, was also used to assess other
potential complications associated with silicone gel-filled
breast implants. The key literature information was discussed
throughout the Breast Implant Complications section above
and the references can be found at the end of this brochure.

3.1 What Are the Overview Findings of

Allergan’s Core Study?
The Allergan Core Study is a 10-year study to assess safety
and effectiveness in augmentation, reconstruction, and
revision (revision-augmentation and revision-reconstruction)
patients. Patient follow-up is at 0-4 weeks, 6 months, 12
months, 24 months, and annually through 10 years. Safety
is assessed by complications, such as implant rupture,
capsular contracture, and reoperation. Benefit (effectiveness)
is assessed by patient satisfaction and measures of quality
of life (QoL).
The Allergan Core Study consists of 715 patients. This
includes 455 primary reconstruction patients, 147 revision-re-
construction patients, 98 primary reconstruction patients, and
15 revision-reconstruction patients. Of these patients,

33
158 primary augmentation patients, 50 revision-augmentation
patients, 51 primary reconstruction patients, and 5 revision-
reconstruction patients are in the MRI cohort, which means
that they are assessed for silent rupture by MRI at years 1,
3, 5, 7, and 9. The study is currently ongoing, with the
results through 7 years reported in this brochure. Allergan
will periodically update this brochure as more information
becomes available. You should also ask your surgeon for any
available updated Allergan clinical information.
Allergan’s Core Study results indicate that the risk of at least
one occurrence of any complication (including reoperation)
at some point through 7 years after implant surgery is 70%
for primary reconstruction patients and 73% for revision-recon-
struction patients. The information below provides more details
about the complications and benefits you may experience.
More detailed data tables are found in the Appendix of this
brochure. Please refer to the glossary for the definition of any
complication you may not understand.

3.2 What Are the 7-year Follow-Up Rates?

Follow-up rates from a clinical study show you how many
women continue to provide information on their experience
with breast implants.
The Allergan Core Study enrolled 98 reconstruction patients.
Of the women expected to be seen at the 7-year follow-up
visit, 87% were seen.
The Allergan Core Study enrolled 15 revision-reconstruction
patients. Of the women expected to be seen at the 7-year
follow-up visit, 83% were seen.

3.3 What Are the Benefits?

The benefits of NATRELLE ® Silicone-Filled Breast Implants were
assessed by a variety of outcomes, including assessments of
patient satisfaction and quality of life. Data were collected
before implantation and at scheduled follow-up visits at 1, 2,
4, and 6 years post-implant for those patients who still had
their original implants and who came back for these visits.

34
Patient Satisfaction: Allergan’s patient satisfaction was based
on a 5-point scale assessment of satisfaction with their
implants at the time of the follow-up visits. Of the original
98 primary reconstruction patients, 63 (64%) provided a
satisfaction rating at 7 years after implantation, with 57 (90%)
of these patients indicating that they were satisfied with their
breast implants.
Of the original 15 revision-reconstruction patients, 10
(67%) provided a satisfaction rating at 7 years. Of these 10
patients, 9 (90%) indicated that they were satisfied with their
breast implants. See Figure 1 below.

Figure 1. Primary Reconstruction and Revision-Reconstruction

Patient Satisfaction Through 7 Years

90% of reconstruction patients

% Patients Satisfied

were satisfied with their implants

90% of revision patients were

satisfied with their implants

Years Primary Revision

Quality of Life Assessments: Quality of life assessments were

obtained prior to implantation and at 1, 2, 4, and 6 years
post-surgery. The 6-year data is provided here. For primary
reconstruction patients, the SF-36, which is a collection of
scales that measure mental and physical health, showed no
changes after 6 years. For patient responses to questions
regarding overall self-concept/self-esteem, there was no
change in self-concept on the Tennessee Self Concept Scale
and no change in overall self esteem on the Rosenberg
Self Esteem Scale 6 years after receiving implants. Patient
responses to questions on the Body Esteem Scale regarding
overall body image also did not show a change 6 years
after receiving implants.

35
For revision-reconstruction patients, responses were similar pre-
and post-implantation on the SF-36, Tennessee Self Concept
Scale, Rosenberg Self Esteem Scale, and Body Esteem Scale
after 6 years.

3.4 What Are the 7-year

Complication Rates?
The complications observed in primary reconstruction and
revision reconstruction women through 7 years are presented
in Table 1 and Table 2, respectively. The rates reflect the
percentage of patients who experienced the listed complication
at least once within the first 7 years after their implantation. Some
complications occurred more than once for some patients. Please
refer to the Glossary at the front of this brochure for the definition
of any complication you may not understand.

The most common complications experienced within the first 7

years of implantation for primary reconstruction patients were
reoperation (53% or approximately 53 patients out of 100)
and implant removal with replacement (24% or approximately
24 patients out of 100). The most common complications
experienced within the first 7 years of implantation for revision-
reconstruction patients were reoperation (40%), asymmetry
(13.3%), and implant malposition (13.3%).

36
 Table 1
7-year Complication Rates for Primary
Reconstruction Patients N = 98 Patients
Key Complications 1 %
Reoperation
5 3.3%

Implant Removal with Replacement 23.7%

Capsular Contracture Baker Grade III/IV 17.1%

Implant Rupture (MRI cohort) 2 11.4%

Implant Removal without Replacement 7.7%

Other Complications Occurring

in ≥ 1% of patients2,3 %%

Asymmetry 22.8%

Wrinkling/Rippling 9.1%

Swelling 7.1%

Breast Pain 4.8%

Scarring/Hypertrophic Scarring 4.5%

Implant Palpability/Visibility 4.1%

Implant Malposition 3.9%

Nipple Complications 3.3%

Infection 3.2%

Tissue/Skin Necrosis 2.3%

Redness 2.1%

Skin Rash 2.0%

Hematoma 1.5%

Bruising 1.0%

Delayed Wound Healing 1.0%

Implant Extrusion 1.0%

Other Complications 1.0%

1
Most events were assessed with severity ratings, and the rates shown in the table include only
complications rated moderate, severe or very severe (excludes mild and very mild ratings). All
occurrences of reoperation, implant removal, implant rupture, implant extrusion and pneumothorax
are included.
2
MRI cohort sample size for Reconstruction equals 51 patients. No ruptures were reported in the
non-MRI cohort, which had a sample size of 47 patients.
3
The following complications were reported at a rate of 0%: breast/skin sensation changes,
capsule calcification, gel migration, irritation, lymphadenopathy, lymphedema, pneumothorax,
ptosis, and seroma/fluid accumulation.

37
 Table 2
7-year Complication Rates for Revision-
Reconstruction Patients N = 15 Patients
2
Key Complications 1 %
Reoperation
4 0.0%

Implant Removal with Replacement 6.7%

Capsular Contracture Baker Grade III/IV 6.7%

Implant Removal without Replacement 0%

Implant Rupture (MRI cohort) 3

0%

Other Complications Occurring

%%
in ≥ 1% of patients4
Asymmetry 13.3%

Implant Malposition 13.3%

Breast Pain 6.7%

Bruising 6.7%

Lymphedema 6.7%

Implant Palpability/Visibility 6.7%

Seroma/Fluid Accumulation 6.7%

Wrinkling/Rippling 6.7%

Skin Rash 6.7%

1
Most events were assessed with severity ratings, and the rates shown in the table include only
complications rated moderate, severe or very severe (excludes mild and very mild ratings).
All occurrences of reoperation, implant removal, implant rupture, implant extrusion and
pneumothorax are included.
2
Calculated as a percentage of enrolled with binomial confidence interval.
3
MRI cohort sample size for Revision-Reconstruction equals 5 patients. No ruptures were
reported in the non-MRI cohort, which had a sample size of 10 patients.
4
The following complications were reported at a rate of 0%: breast/skin sensation changes,
capsule calcification, delayed wound healing, gel migration, hematoma, implant extrusion,
infection, irritation, lymphadenopathy, nipple complications, other complications, pneumothorax,
ptosis, redness, scarring/hypertrophic scarring, swelling, and tissue/skin necrosis.

3.5 What Are the Main Reasons

for Reoperation?
The reasons for reoperation observed in primary reconstruction
and revision-reconstruction women through 7 years are presented
in Table 3 and Table 4, respectively. There may be one or more
reasons identified for having a reoperation (additional surgery

38
after the primary or revision breast reconstruction). Furthermore,
there may be multiple surgical procedures (for example, implant
removal with or without replacement, capsule procedures,
incision and drainage, implant reposition, scar revision, etc.)
performed during a reoperation.

The most common reason for reoperation through 7 years

in primary reconstruction patients was because of implant
malposition (14 of 73 reoperations). In Allergan’s Core Study,
there were 155 surgical procedures performed during 73
reoperations involving 49 primary reconstruction patients.

The most common reason for reoperation through 7 years

in revision-reconstruction patients was because of nipple
complications (5 out of 9 reoperations). In Allergan’s Core
Study, there were 11 surgical procedures performed during 9
reoperations involving 6 revision-reconstruction patients.

Table 3
Main Reasons for Reoperation in Primary
Reconstruction Patients Through 7 Years
Reason for Reoperation n

Implant Malposition 14

Asymmetry 12

Capsular Contracture 10

Need for Biopsy 8

Hematoma/Seroma 6

Ptosis 4

Patient Request for Style/Size Change 3

Scarring/Hypertrophic Scarring 3

Suspected Rupture 3
Breast Cancer, Breast Tissue Contour 2 each
Deformity, Implant Extrusion
Delayed Wound Healing, Necrosis, 1 each
Nipple Complications, Wrinkling

TOTAL 73

39
 Table 4
Main Reasons for Reoperation in
Revision-Reconstruction Patients Through 7 Years
Reason for Reoperation n

Nipple Complications 5

Asymmetry 1

Capsular Contracture 1

Ptosis 1

Scarring/Hypertrophic Scarring 1

TOTAL 9

3.6 What Are the Main Reasons

For Implant Removal?
The main reasons for implant removal observed in primary
reconstruction women through 7 years are presented in
Figure 2. For primary reconstruction, there were 34 implants
removed in 27 patients. Of these 34 implants, 27 were
replaced. The most common reason for implant removal was
implant malposition (9 of the 34 implants removed).

Among revision-reconstruction patients, there was

1 implant removed in 1 patient due to asymmetry.
The implant was replaced.

40
 Figure 2. Main Reasons for Implant Removal Through 7 Years
Primary Reconstruction (n=34)
9 Implant Malposition

7 Asymmetry

7 Capsular Contracture

4 Patient Request for Size/Style Change

3 Suspected Rupture

1 Extrusion

1 Hematoma/Seroma

1 Necrosis

1 Wrinkling/Rippling

3.7 What Are Other Clinical Data Findings?

Below is a summary of clinical findings from the Allergan
Core Study with regard to connective tissue disease (CTD),
CTD signs and symptoms, cancer, lactation complications,
reproduction complications, and suicide. These issues, along
with others, are being further evaluated as part of an Allergan
postapproval study of a large number of patients followed
through 10 years (Breast Implant Follow-Up Study, or BIFS).
CTD Diagnoses

There was 1 primary reconstruction patient (1%) in the

Allergan Core Study who was reported to have a new
diagnosis of an undifferentiated CTD at 3 months after
implantation and 1 patient (1%) with a new diagnosis of
rheumatoid arthritis at 5.5 years after implantation. No
revision-reconstruction patients had new diagnoses of a CTD
through 7 years. It cannot be concluded that these CTD
diagnoses were caused by the implants because there was
no comparison group of similar women without implants.

41
CTD Signs and Symptoms

In Allergan’s Core Study, numerous signs and symptoms were

collected at 2, 4, and 6 years post-implant. For primary
reconstruction patients at 6 years after implantation, a
statistically significant increase was found for the symptom
category of Joint (includes joint pain, stiffness in the morning,
and swelling in other joints or hands). No significant increases
were found in the categories of General, Skin, Muscular,
Neurological, Urinary, Fatigue, Pain, Gastrointestinal,
Fibromyalgia, and Other. For revision-reconstruction patients at
6 years after implantation, no statistically significant increases
were found in any of the symptom categories.
The Core Study was not designed to evaluate cause-and-effect
associations because there is no comparison group of women
without implants, and because other contributing factors,
such as medications and lifestyle/exercise, were not studied.
Therefore, it cannot be determined whether this increase was
due to the implants or not, based on the Core Study. However,
you should be aware that you may experience an increase in
these symptoms after receiving breast implants.
Cancer

There were 8 primary reconstruction patients (8%) with

recurrence of breast cancer through 7 years in the Allergan
Core Study. There was a 17% benign breast disease rate and
a 10% malignant breast disease rate through 7 years.
For revision-reconstruction patients, there were no reports of
new diagnoses or reoccurrence of breast cancer. There was
a 7% benign breast disease rate through 7 years. There were
no reports of other cancers, such as brain, respiratory, or
cervical/vulvar, in primary reconstruction or revision-recon-
struction patients.
Lactation Complications

One of the 98 primary reconstruction patients attempted to

breastfeed following breast implantation in the Allergan Core
Study through 7 years and did not experience any difficulties.
No revision-reconstruction patients attempted to breastfeed
after receiving breast implants.

42
Reproduction Complications

Two (2%) of the primary reconstruction patients in Allergan’s

Core Study reported a reproduction problem through 7
years. No revision-reconstruction patients experienced a
post-implantation reproduction problem.
Suicide

There were no reports of suicide in the primary reconstruction

and revision-reconstruction patients in the Allergan Core
Study through 7 years.

43
44
 4. Surgical
Considerations
4. SURGICAL CONSIDERATIONS FOR
BREAST RECONSTRUCTION
This section provides a discussion of surgical considerations
for primary breast reconstruction, followed by a discussion of
general surgical considerations.
Your decision to have breast reconstruction is an important
personal choice involving both risks and benefits. There are
other options for breast reconstruction that do not involve
breast implants. Be sure to ask your surgeon for a detailed
explanation of each alternative to help you decide which
reconstruction option is most suitable for you and your lifestyle.
This brochure is intended to provide general information about
silicone breast implants and surgery but is not a substitute for
a thorough consultation with your surgeon. You are advised
to carefully review and consider all the information you have
received before deciding whether to have reconstruction
surgery. Prepare a list of questions after reading this brochure,
and discuss them with your surgeon.

4.1 Should You Have Primary Breast

Reconstruction?
Whether you decide to have breast reconstruction depends on
your own individual case, medical condition, general health,
lifestyle, emotional state, and breast size and shape. You
should consult your surgeon to discuss your personal goals for
breast reconstruction, and you may also consider consulting
your family, friends, breast implant support groups, and breast
cancer support groups to help you in making this decision.
If you are considering breast reconstruction and do not have
a reconstructive surgeon, ask your general surgeon for the
names of experienced, board-certified surgeons in your area.
Your general surgeon, breast reconstruction surgeon, and
oncologist should work together to plan your mastectomy and
reconstruction procedure and to advise you based on your
specific clinical needs and desired outcome.

45
You should also be aware that, for primary reconstruction
patients, alternatives may include:
• Accepting your breasts as they are and
having no surgery.
• Wearing a padded bra or external prostheses.
• Having reconstruction using your own tissue
(flap procedure).
• Having surgery with saline implants.
For revision-reconstruction patients, alternatives may include:
• No revision.
• Removal with or without replacement.

4.2 What Are the Options in Primary

Breast Reconstruction?
You may choose not to undergo breast reconstruction. In this
case, you may or may not decide to wear an external breast
form (prosthesis) inside your bra. Breast forms are available
in a variety of shapes, sizes, and materials such as foam,
cotton, and silicone. Custom prostheses are also available to
match the size and shape of your breast.

4.3 What Are the Choices in Primary

Reconstructive Procedures?
The type of breast reconstruction procedure available to you
depends on your medical situation, breast shape and size,
general health, lifestyle, and goals.
Breast reconstruction can be accomplished by the use
of a prosthesis (a breast implant, either silicone gel- or
saline-filled), your own tissues (a tissue flap), or a combination
of the two. A tissue flap is a combination of skin, fat, and/
or muscle that is moved from your stomach, back, or other
area of your body to the chest area, and shaped into a
new breast. A tissue flap also may be used to provide skin
or other tissue needed to make up for what was removed at
the time of surgery, or changed following radiation therapy.
Your surgeon can help you decide what method of breast
reconstruction is most suitable for your particular situation.

46
Whether or not you have reconstruction with or without breast
implants, you will probably undergo additional surgeries
to improve symmetry and appearance. These additional
surgeries may be part of a several-stage reconstruction of
the removed breast, or to shape the remaining breast to
bring it into better balance with the reconstructed one. Most
commonly, breast implants are placed after a space has been
created for them using a temporary soft tissue expander that
can be placed at the time of mastectomy or at a later time.
Portions of the reconstruction may be done in stages. For
example, because the nipple and areola are usually removed
with the breast tissue in mastectomy, the nipple is usually
reconstructed by using a skin graft from another area of the
body or the opposite breast, in addition to tattooing the area
to obtain a better color match. Nipple reconstruction is usually
done as a separate outpatient procedure after the initial
reconstruction surgery is complete.

4.4 What is Breast Reconstruction With

Breast Implants?
Your surgeon will decide whether your health and medical
condition makes you an appropriate candidate for breast
implant reconstruction. Women with small or medium-sized
breasts are the best candidates for breast reconstruction with
implants.Women with larger breasts may require reconstruction
with a combination of a tissue flap and an implant. Your
surgeon may recommend breast implantation of the opposite,
uninvolved breast in order to make your breasts more alike
(maximize symmetry), or he/she may suggest breast reduction
(reduction mammoplasty) or a breast lift (mastopexy) to improve
symmetry. Mastopexy involves removing a strip of skin from
under the breast or around the nipple and using it to lift and
tighten the skin over the breast. Reduction mammoplasty
involves removal of breast tissue and skin. If it is important
to you not to alter the unaffected breast, you should discuss
this with your plastic surgeon, as it may affect the breast
reconstruction methods considered for your case.

47
4.5 What Reconstruction Incision Sites
Are Used?
In reconstructive surgery, the incision placement and length is
decided by your surgeon, and largely influenced by the type
of cancer surgery that is planned for you.
Most implants in breast reconstruction use the mastectomy
scar either immediately (during the mastectomy procedure)
or after tissue expansion.

4.6 What About the Surgical Settings

and Anesthesia?
Reconstruction surgery is usually performed on an inpatient
basis in an operating room when it begins at the same
time as the mastectomy. Some of the stages, such as nipple
reconstruction, or placement of the implant after soft tissue
expansion, can be done as an outpatient. General anesthesia
is most often used.

4.7 What Is the Timing of Primary Breast

Implant Reconstruction?
The following description applies to reconstruction following
mastectomy, but similar considerations apply to reconstruction
following breast trauma or reconstruction for congenital
anomalies. The breast reconstruction process may begin at the
time of your mastectomy (immediate reconstruction) or months
to years afterwards (delayed reconstruction). This decision
is made after consultation with the cancer treatment team
based on your individual situation. Immediate reconstruction
may involve placement of a breast implant, but typically
involves placement of a tissue expander, which is used to
recreate skin that was removed during the cancer surgery.
The tissue expander will eventually be replaced with a breast
implant. It is important to know that any type of surgical breast
reconstruction may take several steps to complete.

48
A potential advantage to immediate reconstruction is that your
breast reconstruction starts at the time of your mastectomy and
that there may be cost savings and potentially fewer days in the
hospital for you in combining the mastectomy procedure with the
first stage of the reconstruction. However, there may be a higher
risk of capsular contracture, extrusion, and other complications
associated with immediate reconstruction as a result of
postoperative radiation and chemotherapy treatments. Your
initial operative time and recovery time may also be longer.
A potential advantage to delayed reconstruction is that you
can delay your reconstruction decision and surgery until other
treatments, such as radiation therapy and chemotherapy, are
completed. Delayed reconstruction may be advisable if your
surgeon anticipates healing problems with your mastectomy,
or if you just need more time to consider your options.
There are medical, financial, and emotional considerations to
choosing immediate versus delayed reconstruction. You should
discuss with your general surgeon, reconstructive surgeon,
and oncologist the pros and cons of the options available in
your individual case.

4.8 What Is the Primary Breast Implant

Reconstruction Procedure?
Immediate or Delayed Breast Implant Reconstruction

Breast reconstruction using only a breast implant may be

done immediately at the time of your mastectomy or sometime
thereafter. After the general surgeon removes your breast tissue,
the plastic surgeon will then implant a breast implant that
completes the reconstruction. In reconstruction following
mastectomy, a breast implant is most often placed submuscularly.
Expander-Assisted (Immediate or Delayed)
Breast Implant Reconstruction

Breast reconstruction usually occurs as a multistage procedure,

starting with the placement of a breast tissue expander, which is
replaced several months later with a breast implant. The tissue
expander placement may be done immediately, at the time of
your mastectomy, or be delayed until months or years later.

49
 Side View: Side View:
Breast Tissue Expander Inserted
Removed and Filled

Tissue Expansion

During a mastectomy, the general surgeon removes skin as

well as breast tissue, leaving the chest tissues flat and tight. To
create a breast shaped space for the breast implant, a tissue
expander is placed under the remaining chest tissues.
The tissue expander is a balloon-like device made from elastic
silicone rubber. It is inserted unfilled, and over time, sterile
saline fluid is added by inserting a small needle through the
skin to the filling port of the device. As the tissue expander fills,
the tissues over the expander begin to stretch, similar to the
gradual expansion of a woman’s abdomen during pregnancy.
The tissue expander creates a new breast-shaped pocket for a
breast implant.
Tissue expander placement usually occurs under general
anesthesia in an operating room. Operative time is generally
1 to 2 hours. The procedure may require a brief hospital stay
or be done on an outpatient basis. Typically, you can resume
normal daily activity after 2 to 3 weeks.
Because the chest skin is usually numb from the mastectomy
surgery, it is possible that you may not experience pain from
the placement of the tissue expander. However, you may
experience feelings of pressure, tightness, or discomfort after
each filling of the expander, which subsides as the tissue
expands but may last for a week or more. Tissue expansion
typically takes four to six months.

50
Placing the Breast Implant

After the tissue expander is removed, the breast implant is

placed in the pocket. In reconstruction, following mastectomy, a
breast implant is most often placed submuscularly. The surgery
to replace the tissue expander with a breast implant (implant
exchange) is usually done under general anesthesia in an
operating room. It may require a brief hospital stay or be done
on an outpatient basis.

Post Mastectomy Stage 1: Stage 2:

Tissue Expander Placed Breast Implant and Nipple/
and Expansion Under Way Areola Reconstruction

4.9 What About Primary Breast

Reconstruction Without Implants
(Tissue Flap Procedures)?
The breast can be reconstructed by surgically moving a
section of skin, fat, and muscle from one area of your body to
another. The section of tissue may be taken from such areas
as your abdomen, upper back, upper hip, or buttocks.
The tissue flap may be left attached to the blood supply and
moved to the breast area through a tunnel under the skin
(a pedicled flap), or it may be removed completely and
reattached to the breast area by microsurgical techniques (a
free flap). Operating time is generally longer with free flaps,
because of the microsurgical requirements.
Flap surgery requires a hospital stay of several days and
generally a longer recovery time than implant reconstruction.
Flap surgery also creates scars at the site where the flap was

51
taken and on the reconstructed breast. However, flap surgery
has the advantage of being able to replace tissue in the chest
area. This may be useful when the chest tissues have been
damaged and are not suitable for tissue expansion. Another
advantage of flap procedures over implant reconstruction is
that alteration of the unaffected breast is generally not needed
to improve symmetry.
The most common types of tissue flaps are the TRAM
(transverse rectus abdominus musculocutaneous flap, which
uses tissue from the abdomen) and the Latissimus dorsi flap
(which uses tissue from the upper back).
It is important for you to be aware that flap surgery,
particularly the TRAM flap, is a major operation, and more
extensive than your mastectomy operation. It requires good
general health and strong emotional motivation. If you are
very overweight, smoke cigarettes, have had previous surgery
at the flap site, or have any circulatory problems; you may
not be a good candidate for a tissue flap procedure. Also,
if you are very thin, you may not have enough tissue in your
abdomen or back to create a breast mound with this method.
The TRAM Flap (Pedicle or Free)

During a TRAM flap procedure, the surgeon removes a

section of tissue from your abdomen and moves it to your
chest to reconstruct the breast. The TRAM flap is sometimes
referred to as a “tummy tuck” reconstruction, because it may
leave the stomach area flatter.
A pedicle TRAM flap procedure typically takes 3 to 6 hours
of surgery under general anesthesia; a free TRAM flap
procedure generally takes longer. The TRAM procedure may
require a blood transfusion. Typically, the hospital stay is 2
to 5 days. You can resume normal daily activity after 6 to 8
weeks. Some women, however, report that it takes up to 1
year to resume a normal lifestyle. You may have temporary
or permanent muscle weakness in the abdominal area. If
you are considering pregnancy after your reconstruction, you
should discuss this with your surgeon. You will have a large
scar on your abdomen and may also have additional scars
on your reconstructed breast.

52
 Post Mastectomy TRAM Flap Final Result with
Nipple/Areola
THIS RECONSTRUCTION INCLUDES A MASTOPEXY Reconstruction
TO THE OTHER BREAST TO IMPROVE SYMMETRY

The Latissimus Dorsi Flap With or Without Breast Implants

During a Latissimus Dorsi flap procedure, the surgeon moves

a section of tissue from your back to your chest to reconstruct
the breast. Because the Latissimus Dorsi flap is usually thinner
and smaller than the TRAM flap, this procedure may be more
appropriate for reconstructing a smaller breast.
The Latissimus Dorsi flap procedure typically takes 2 to 4 hours
of surgery under general anesthesia. Typically, the hospital
stay is 2 to 3 days. You can resume daily activity after 2 to 3
weeks. You may have some temporary or permanent muscle
weakness and difficulty with movement in your back and
shoulder. You will have a scar on your back, which can usually
be hidden in the bra line. You may also have additional scars
on your reconstructed breast.

Post Mastectomy View Showing Latissimus Dorsi

Back Scar Flap and Nipple/Areola
Reconstructon

53
4.10 W
 hat Are Some General
Surgical Considerations?
Choosing a Surgeon
When choosing a surgeon who is experienced with breast
reconstruction, you should find out the answers to the
following questions:
• How many breast reconstruction implantation
procedures does he/she perform per year?
• How many years has he/she performed breast
reconstruction procedures?
• Has he/she completed Allergan’s Physician Certification
Program for the use of its silicone-filled breast implants?
• Is he/she board certified, and if so, with which board?
• In which state(s) is he/she licensed to practice surgery?
(Note that some states provide information
on disciplinary action and malpractice claims/
settlements to prospective patients, either by request
or on the Internet.)
• What is the most common complication he/she
encounters with breast reconstruction?
• What is his/her reoperation rate with breast
reconstruction, and what is the most common type of
reoperation he/she performs?
• Can he/she perform this surgery in a hospital, as well
as in the surgeon’s independent surgery center? (Note
that hospitals require evidence of appropriate training
in specific procedures before allowing surgeons to
operate in their facilities.)
Insurance
In general, private insurance that covers medically
necessary mastectomies will also cover breast reconstructive
surgery. Insurance coverage for reoperation procedures
or additional surgeon’s visits following reconstruction may
not be covered, depending on the policy. For example, a
reoperation may include temporary removal of the implant
to facilitate the oncologist’s ongoing surveillance for breast
cancer recurrence. Because coverage policies vary and can
change over time, no guidance can be given with respect

54
to coverage under any particular health plan. It is, therefore,
recommended that you contact your health plan to obtain
specific information regarding its coverage policies before
deciding to proceed with reconstructive surgery.
What Are Choices and Options Associated
With The Surgery?
There are two approved types of breast implant fillers, saline
and silicone, which gives more options to you in terms of
the type of implant to achieve the effect you desire. Your
surgeon can discuss these options with you and may make
recommendations to you based upon the physical contours of
your body. The focus of this brochure is silicone-filled breast
implants; a separate brochure is available for saline-filled
implants. Carefully review the section on complications and
the section on Allergan’s clinical study so that you may make
an informed choice. Be sure to ask your surgeon to see and
touch samples of both silicone and saline breast implants.
Implant Shape and Size
Depending on the desired shape you wish to achieve, you
and your surgeon have implants with different round profiles,
or styles, from which to choose. Generally, the larger you
want your cup size, the larger the breast implant the surgeon
will consider (measured in cubic centimeters, or cc’s, not in
cup sizes, because cup size depends on the size and shape
of the individual woman’s chest).
Your surgeon will also evaluate your existing breast and skin
tissue to determine if you have enough to cover the breast
implant you are considering, or, in some cases such as after
pregnancy, too much extra skin. If you desire a breast implant
size that is too large for your tissue, the surgeon may warn
you that breast implant edges may be visible or palpable
postoperatively. Also, excessively large breast implants may
speed up the effects of gravity on the breast, and can result
in droop or sag at an earlier age. A recent report indicates
that larger-sized implants (greater than 350cc) may be too
large for many women, increasing the risk of developing
complications such as implant extrusion, hematoma, infection,
palpable implant folds, and visible skin wrinkling requiring
surgical intervention to correct these complications.7

55
Surface Texturing
Some studies suggest that surface texturing reduces the
chance of severe capsular contracture,9 while other studies
do not.7,8 Allergan’s Core Study did not show a difference
in the likelihood of developing capsular contracture with
textured implants compared to smooth implants.
A textured implant may require a larger incision because the
rougher textured surface may make it harder to place into
the pocket without undue stress, which might damage the
implant or decrease its durability.
Implant Palpability
Implants may be more palpable or noticeable if there is
an insufficient amount of skin/tissue available to cover the
implant and/or when the implant is placed subglandularly.
Postoperative Care
You will probably feel somewhat tired and sore for several
days following the operation, and your breasts may remain
swollen and sensitive to physical contact for a month or
longer. You may also experience a feeling of tightness in
the breast area as your skin adjusts to your new breast
size. The feeling in the breasts and nipple area also may
be diminished during this time of swelling and immediate
post-surgery recovery. Other possible complications are
described in the Breast Implant Complications section.
Postoperative care depends on each patient’s situation
and may involve the use of a special postoperative bra,
compression bandage, or jog bra for extra support and
positioning while you heal. Some surgeons may not want
you to wear a bra at all for a period of time following
the surgery. At your surgeon’s recommendation, you will
most likely be able to return to work within a few days,
although for at least a couple of weeks you should avoid
any strenuous activities that could raise your pulse and
blood pressure, or require strenuous use of your arms and
chest. Your surgeon may also recommend breast massage
exercises.

56
Note: If you experience fever, do not feel well, or
see noticeable swelling and/or redness or drainage in
your implanted breast(s), you should contact your
surgeon immediately.
Other Factors to Consider In
Revision-Reconstruction Surgery
Some revision surgeries require removal of an intact implant
(for example, capsulotomy and pocket adjustments), while
others do not require removal of the implant. Any device
that has been removed during revision surgery should not be
reimplanted. Allergan breast implants are “for single use only.”

57
58
5. Follow-up
Examinations
5. FOLLOW-UP EXAMINATIONS
Breast Self-Examinations
Following breast reconstruction you should continue to
perform a breast self-examination monthly. This may be more
difficult with a breast implant in place. To continue to perform
a monthly breast self examination efficiently, you should ask
your surgeon to help you identify the difference between
the implant and your breast tissue. Being able to identify
the implant from breast tissue will decrease the necessity
of excessive squeezing of the implant during examination.
Any new lumps should be evaluated with a biopsy, as
appropriate. If a biopsy is performed, be sure to inform
the medical professional performing the biopsy that you
have breast implants so that care will be taken to avoid
damaging the implant.
SCREENING FOR SILENT RUPTURE
Because most ruptures of silicone-filled breast implants are
silent, in most cases neither you nor your surgeon will be
able to find evidence of rupture. Therefore, evaluation of
your implants is needed to screen for implant rupture. The
best method of screening is currently MRI at a center with
a breast coil, with a magnet of at least 1.5 Tesla. The MRI
should be read by a radiologist who is familiar with looking
for implant rupture.
It is recommended that your first MRI evaluation take place
starting at 3 years after implant surgery and then every 2
years, thereafter, even if you are experiencing no problems
with your implant. If signs of rupture are seen on MRI, then
you should have your implant removed, with or without
replacement. Your doctor should assist you in locating a
radiology/screening center, as well as a radiologist who is
familiar with the technique and equipment for proper MRI
screening for silent rupture of your breast implant.
Symptomatic Rupture
Symptoms associated with rupture may include hard knots or
lumps surrounding the implant or in the armpit, loss of size
of the breast or implant, pain, tingling, swelling, numbness,
burning, or hardening of the breast. If you notice any of

59
these changes, see your plastic surgeon so that he or she
can examine the implants and determine whether you need
to have an MRI examination to find out if your symptoms are
due to rupture of the implant. If rupture has occurred, you
should have your implant removed. Consult with your doctor
regarding this and any other medical decisions related to
your implants. More information on rupture is provided in
section 4 of this brochure.
Mammography
The current recommendations for getting screening/preoperative
mammograms are no different for women with breast implants
than for those without implants. Mammography exams should
be interpreted by radiologists experienced in the evaluation
of women with breast implants. It is essential that you tell your
mammography technologist before the procedure that you have
an implant. You should request a diagnostic mammogram,
rather than a screening mammogram, because more pictures
are taken with diagnostic mammography. The technologist
can use special techniques to reduce the possibility of rupture
and to get the best possible views of the breast tissue.

60
 Additional
Information
6. ADDITIONAL INFORMATION
6.1 What Types of NATRELLE® Silicone
Filled Breast Implants Are Available
from Allergan?
NATRELLE ® Silicone-Filled Breast Implants come in a variety
of profiles and sizes with either a textured shell or smooth
surface shell. Your plastic surgeon will discuss with you the
implant design that will best help you achieve the result that
is right for you.
Examples of NATRELLE® Smooth and Textured Implant Styles

Smooth Implant Textured Implant

The following diagram may help you to understand the

projections of implants as your surgeon discusses the various
options with you.

Moderate Moderate-Plus High Profile Extra-High Profile

A=Width, B=Projection

61
Approved Allergan Implant Styles

Style Number Breast Implant Description Size Range

Style 10 Smooth shell surface, moderate profile 120cc–800cc

Style 15 Smooth shell surface, moderate-plus profile 155cc–752cc

Style 20 Smooth shell surface, high profile 120cc–800cc

Style 40 Smooth shell surface, moderate profile 80cc–560cc

Style 45 Smooth shell surface, extra-high profile 120cc–800cc

Style 110 BIOCELL textured shell surface,
®
90cc–510cc
moderate profile
Style 115 BIOCELL® textured shell surface, 150cc–716cc
moderate-plus profile
Style 120 BIOCELL® textured shell surface, 180cc–650cc
high profile

6.2 What If I Experience a Problem?

You will be given a device identification card with the style
and serial number of your breast implant(s). This card is for
your permanent record and should be kept in a safe place. In
the event you have a concern or problem with your implant,
you can use this card to describe the implant to your health
care provider or to Allergan.
You should immediately report any problems that you notice
with your implants to your plastic surgeon. If you believe that
you have experienced a serious problem(s) related to your
breast implants, you should have your health professional
report the problem(s) to the Food and Drug Administration
(FDA) and/or to Allergan. You may also report any serious
problem directly through the FDA’s MedWatch voluntary
reporting system. An adverse event is considered serious
and should be reported when it results in a hospitalization,
disability, congenital problem with your child, or other
medical or surgical intervention. The information reported to
MedWatch is entered into databases to be used to follow
safety trends (patterns) of a device and to determine whether
further follow-up of any potential safety issues related to the
device is needed.

62
To report, use MedWatch form 3500, which may be
obtained through FDA’s website at
http://www.fda.gov/medwatch/index.html. You may also
call 1.888.463.INFO.FDA (1.888.463.6332), from 10
am-4 pm Eastern Time, Monday through Friday, to receive
an additional FDA MedWatch Package. Keep a copy of the
MedWatch form completed by your surgeon for your records.

6.3 What Is Device Tracking?

Silicone gel-filled breast implants are subject to Device
Tracking by Federal regulation. This means that your physician
will be required to submit to Allergan the serial number of
the implant(s) you receive, the date of surgery, information
relating to the physician’s practice and information on the
patient receiving the implant(s). Your surgeon will write
this information on the Device Tracking Form supplied by
Allergan with each silicone-filled breast implant. Your surgeon
will return the top portion of the form to Allergan following
surgery. The bottom portion of the form will be provided to
you following surgery. You have the right to remove your
personal information from Allergan’s Device Tracking program.
If you choose NOT to participate in Device Tracking, please
check the appropriate box on the Device Tracking form
and return to Allergan. You also have the right to have your
personal information withheld from disclosure to third parties
who may request information from Allergan, such as the FDA.
If you choose to participate in the Device Tracking program
but do NOT want your personal information to be released to
third parties, please also check the appropriate box.
Allergan strongly recommends that all patients receiving
NATRELLE ® Silicone-Filled Breast Implants participate in
Allergan’s Device Tracking program. This will help ensure that
Allergan has a record of each patient’s contact information
so that all patients, including you, can be contacted in the
case of a recall or other problems with your implants that you
should be made aware of.
You are encouraged to complete the Device Tracking Form
you received following surgery and return it to Allergan in the
postage paid business reply envelope provided. Please inform
Allergan whenever your contact information changes.

63
Assessment of Information Effectiveness

The “Required Information” section of the Device Tracking

Form also has a question designed to assess the effectiveness
of the Breast Reconstruction with NATRELLE ® Silicone-Filled
Breast Implants patient planner provided prior to your surgery.
This question asks you to verify that you received and had
adequate time to review this patient labeling information.
Please check either yes or no. When the Required Information
section is complete, return it to Allergan in the postage-paid
business reply envelope provided.

6.4 What Are the ConfidencePlus®

Limited Warranties?
The ConfidencePlus® Limited Warranties provide lifetime
replacement and limited financial reimbursement in the
event of shell leakage or breakage resulting in implant
rupture, subject to certain conditions as fully discussed in
the ConfidencePlus® literature. Allergan offers two levels
of coverage under its warranty program. Our standard
ConfidencePlus® Limited Warranty program applies
automatically to every Allergan breast implant recipient
subject to the conditions discussed in the ConfidencePlus®
literature. The optional ConfidencePlus® Premier Limited
Warranty program is available for a low enrollment fee and
increases the financial benefit in the event of implant rupture,
subject to the conditions discussed in the ConfidencePlus®
literature. For more information, please visit
www.cppwarranty.com or contact Allergan’s Product Support
Department at 1.800.362.4426.

6.5 How Can I Receive More Information?

Upon request, you will be provided with a copy of the
package insert (Directions for Use; NATRELLE ® Silicone-Filled
Breast Implants document). You can request a copy from your
surgeon or from Allergan. It can also be found on
www.NATRELLE.com. The package insert has many undefined
medical and technical terms because it contains information
directed only to the surgeon.

64
For more detailed information on the preclinical and clinical
studies conducted by Allergan, you are referred to the
Summary of Safety and Effectiveness Data (SSED) for this
product which may be accessed at
http://www.fda.gov/cdrh/breastimplants/.

65
If, after reading this information, you have additional
questions about breast implants or breast implant surgery,
there are a number of resources available to you.
Toll-Free Number
If you are a patient or a prospective patient and wish to
speak to an Allergan Breast Implant Support Specialist to
inquire about breast implants, discuss any concerns, or
request a copy of the patient labeling or package insert
(Directions for Use), call toll free at 1.800.362.4426
(7 am to 5 pm Pacific Time).
Additional Resources
Allergan
1.800.624.4261
www.NATRELLE.com
www.allergan.com
www.breastimplantanswers.com
Institute of Medicine Report on the Safety of Silicone Implants
www.nap.edu/catalog/9618.html
Food and Drug Administration
1.888.INFO-FDA or 1.240.276.3103
www.fda.gov/cdrh/breastimplants

66
FOR FURTHER READING AND INFORMATION
Overall Safety Assessment
1. Bondurant, S., Ernster, V., and Herdman, R., Eds. 2000. Safety of
silicone breast implants. Committee on the Safety of Silicone Breast
Implants, Division of Health Promotion and Disease Prevention,
Institute of Medicine. Washington, D.C.: National Academy Press.
Implant Rupture
2. Hedén, P., et al. 2006. Prevalence of rupture in Inamed silicone
breast implants. Plast. Reconstr. Surg. 118:303-8.
3. Hölmich, L.R., et al. 2005. The diagnosis of silicone breast implant
rupture. Clinical findings compared to findings at MRI. Ann. Plast.
Surg. 54(6):583-9.
4. Hölmich, L.R., et al. 2005. The diagnosis of breast implant rupture:
MRI findings compared to findings at explantation. 2005. Eur. J.
Radiol. 53:213-25.
5. Hölmich, L.R., et al. 2004. Untreated silicone breast implant rupture.
Plast. Reconstr. Surg. 114:204-14.
6. Hölmich, L.R., et al. 2001. Prevalence of silicone breast implant
rupture among Danish women. Plast. Reconstr. Surg.
108(4):848-58.
Capsular Contracture
7. Henriksen, T.F., et al. 2005. Surgical intervention and capsular
contracture after breast augmentation: a prospective study of risk
factors. Ann. Plast. Surg. 54(4):343-51.
8. Kulmala, I., et al. 2004. Local complications after cosmetic breast
implant surgery in Finland. Ann. Plast. Surg. 53(5):413-9.
9. Seify, H., et al. 2005. Preliminary (3 years) experience with smooth
wall silicone gel implants for primary breast augmentation. Ann.
Plast. Surg. 54(3):231-5.
Connective Tissue Disease (CTD)
10. Brinton, L.A., et al. 2004. Risk of connective tissue disorders among
breast implant patients. Am. J. Epidemiol. 160(7):619-27.
11. Brown, S.L., et al. 2001. Silicone gel breast implant rupture,
extracapsular silicone, and health status in a population of women.
J. Rheumatol. 28:996-1003.
12. Hölmich, L.R., et al. 2003. Self-reported diseases and symptoms by
rupture status among unselected Danish women with cosmetic
silicone breast implants. Plast. Reconstr. Surg. 111:723-32.

67
13. Janowsky, E.C., et al. 2000. Meta-analyses of the relation between
silicone breast implants and the risk of connective-tissue diseases. N.
Engl. J. Med. 342(11):781-90.
14. Lipworth, L., et al. 2004. Silicone breast implants and connective
tissue disease: An updated review of the epidemiologic evidence.
Ann. Plast. Surg. 52:598-601.
15. Tugwell, P., et al. 2001. Do silicone breast implants cause
rheumatologic disorders? A systematic review for a court-appointed
national science panel. Arthritis Rheum. 44(11):2477-84.
16. Weisman, M.H., et al. 1988. Connective-tissue disease following
breast augmentation: A preliminary test of the human adjuvant tissue
hypothesis. Plast. Reconstr. Surg. 82(4):626-30.
17. Williams, H.J., et al. 1997. Breast implants in patients with
differentiated and undifferentiated connective tissue disease. Arthritis
Rheum. 40(3):437-40.
18. Wolfe, F. and Anderson, J. 1999. Silicone filled breast implants
and the risk of fibromyalgia and rheumatoid arthritis. J. Rheumatol.
26:2025-28.
CTD Signs and Symptoms
19. Berner, I.,et al. 2002. Comparative examination of complaints of
patients with breast-cancer with and without silicone implants. Eur. J
Obstet. Gynecol. Reprod. Biol. 102:61-6.
20. Breiting, V.B., et al. 2004. Long-term health status of Danish women
with silicone breast implants. Plast. Reconstr. Surg. 114:217-26.
21. Fryzek, J.P., et al. 2001. Self-reported symptoms among women
after cosmetic breast implant and breast reduction surgery. Plast.
Reconstr. Surg. 107:206-13.
22. Kjøller, K., et al. 2004. Self-reported musculoskeletal symptoms
among Danish women with cosmetic breast implants. Ann. Plast.
Surg. 52(1):1-7.
Cancer
23. Brinton, L.A., et al. 2000. Breast cancer following augmentation
mammoplasty (United States). Cancer Causes Control.
11(9):819-27.
24. Brinton, L.A., et al. 2001. Cancer risk at sites other than the breast
following augmentation mammoplasty. Ann. Epidemiol. 11:248-56.
25. Bryant, H., and Brasher, P. 1995. Breast implants and breast cancer–
reanalysis of a linkage study. N. Engl. J. Med. 332(23):1535-9.
26. Cook, L.S. 1997. Characteristics of women with and without breast
augmentation. JAMA. 20:1612-7.

68
27. Deapen, D.M., et al. 1997. Are breast implants anticarcinogenic?
A 14-year follow-up of the Los Angeles Study. Plast. Reconstr. Surg.
99:1346-53.
28. Deapen, D., et al. 2000. Breast cancer stage at diagnosis and
survival among patients with prior breast implants. Plast. Reconstr.
Surg. 105:535-40.
29. Fryzek, J.P., et al. 2000. Characteristics of women with cosmetic
breast augmentation surgery compared with breast reduction surgery
patients and women in the general population of Sweden. Ann. Plast.
Surg. 45(4):349-56.
30. Herdman, R.C., et al. 2001. Silicone breast implants and cancer.
Cancer Invest. 19(8):821-32.
31. Jakubietz, M.G., et al. 2004. Breast augmentation: Cancer
concerns and mammography–A literature review. Plast. Reconstr.
Surg. 113:117e-22e.
32. Kjøller K., et al. 2003. Characteristics of women with cosmetic
breast implants compared with women with other types of cosmetic
surgery and population-based controls in Denmark. Ann. Plast. Surg.
50(1):6-12.
33. McLaughlin, J.K. and Lipworth, L. 2004. Brain cancer and cosmetic
breast implants: A review of the epidemiological evidence. Ann.
Plast. Surg. 52(2):15-17.
34. Miglioretti, D.L., et al. 2004. Effect of breast augmentation on
the accuracy of mammography and cancer characteristics. JAMA.
291(4):442-50.
35. Pukkala, E., et al. 2002. Incidence of breast and other cancers
among Finnish women with cosmetic breast implants, 1970-1999. J.
Long Term Eff. Med. Implants. 12(4):271-9.
Suicide
36. Brinton, L.A., et al. 2001a. Mortality among augmentation
mammoplasty patients. Epidemiol. 12(3):321-6.
37. Jacobsen, P.H., et al. 2004. Mortality and suicide among Danish
women with cosmetic breast implants. Arch. Int. Med.
164(22):2450-5.
38. Koot, V., et al. 2003. Total and cause specific mortality among
Swedish women with cosmetic breast implants: prospective study.
BMJ. 326(7388):527-8.
39. Pukkala, E., et al. 2003. Causes of death among Finnish
women with cosmetic breast implants, 1971-2001. Ann. Plast. Surg.
51(4):339-42.

69
Effects on Breastfeeding/Children
40. Hemminki, E., et al. 2004. Births and perinatal health of infants
among women who have had silicone breast implantation in Finland,
1967-2000. Acta Obstet. Gynecol. Scand. 83(12):1135-40.
41. Kjøller, K., et al. 2002. Health outcomes in offspring of Danish
mothers with cosmetic breast implants. Ann. Plast. Surg. 48:238-45.
42. Signorello, L.B., et al. 2001. Offspring health risk after cosmetic
breast implantation in Sweden. Ann. Plast. Surg. 46:279-86.
Silicone Gel Migration
43. Katzin, W.E., et al. 2005. Pathology of lymph nodes from patients
with breast implants: a histologic and spectroscopic evaluation. Am.
J. Surg. Pathol. 29(4):506-11.
Gel Bleed
44. Chandra, G., et al. 1987. A convenient and novel route to
bis(alkyne)platinum(0) and other platinum(0) complexes from Speier’s
hydrosilylation catalyst. Organometallics. 6:191-2.
45. Flassbeck, D.B., et al. 2003. Determination of siloxanes, silicon,
and platinum in tissues of women with silicone gel-filled implants.
Anal. Bioanal. Chem. 375(3):356-62 (for example, data from
Patients B & C).
46. Lappert, M.F. and Scott, F.P.A. 1995. The reaction pathway from
Speier’s to Karstedt’s hydrosilylation catalyst. J. Organomet. Chem.
492(2):C11-C13.
47. Lewis, L.N., et al. 1995. Mechanism of formation of platinum(0)
complexes containing silicon-vinyl ligands. Organometallics.
14:2202-13.
48. Lugowski, S.J., et al. 2000. Analysis of silicon in human tissues with
special reference to silicone breast implants. J. Trace Elem. Med.
Biol. 14(1):31-42.
49. Stein, J., et al. 1999. In situ determination of the active catalyst in
hydrosilylation reactions using highly reactive Pt(0) catalyst precursors.
J. Am. Chem. Soc. 121(15):3693-703.

70
71
INDEX
Alternatives................................................................................ 46
Anesthesia................................................................................ 48
Breast Implant Follow-Up Study, or BIFS........................................... 18
Breast reconstruction........................................................ 14, 45, 46
Delayed................................................................................. 48
Immediate............................................................................... 48
Breast self-examination................................................................. 59
Breast tissue atrophy.................................................................... 28
Breast tissue expander................................................................. 49
Breastfeeding................................................................. 27, 31, 42
Calcium deposits........................................................................ 27
Cancer............................................................................... 30, 42
Capsular contracture................................................................... 23
Chest wall deformity.................................................................... 28
Complications...................................................................... 19, 36
ConfidencePlus®......................................................................... 64
Connective tissue disease (CTD).................................................... 29
Contraindications....................................................................... 14
Core Study................................................................................ 33
CTD......................................................................................... 41
CTD signs and symptoms....................................................... 29, 42
Delayed wound healing............................................................... 28
Device identification card............................................................. 62
Device tracking.......................................................................... 63
Effects on children....................................................................... 31
Extrusion................................................................................... 27
Food and Drug Administration (FDA)............................................... 62
Gel diffusion.............................................................................. 31
Hematoma/seroma.................................................................... 26
Implant palpability...................................................................... 56

72
Implant removal.................................................................... 24, 40
Implant shape and size................................................................ 55
Indications................................................................................ 13
Infection.................................................................................... 26
Lactation complications................................................................ 42
Latissimus Dorsi flap procedure...................................................... 53
Lymphadenopathy....................................................................... 28
Mammography.................................................................... 16, 60
MedWatch............................................................................... 62
MRI......................................................................................... 59
Necrosis................................................................................... 27
Neurological disease.................................................................. 30
Pain......................................................................................... 25
Patient satisfaction...................................................................... 35
Postoperative care...................................................................... 56
Precautions................................................................................ 14
Quality of life assessments............................................................ 35
Reoperation......................................................................... 24, 38
Reproduction complications.......................................................... 43
Rupture............................................................................... 16, 19
Rupture from literature.................................................................. 21
Rupture information on Allergan implants......................................... 20
Screening................................................................................. 59
Silent rupture.............................................................................. 59
Suicide............................................................................... 31, 43
Summary of Safety and Effectiveness Data (SSED)............................. 65
Surgeon.................................................................................... 54
Surgical Setting.......................................................................... 48
Symptomatic rupture.................................................................... 59
Tissue flap................................................................................. 46
TRAM flap procedure.................................................................. 52
Unsatisfactory results................................................................... 25

73
74
forms
Checklists for you and
your surgeon to review

pre-op & post-op

checklist
Preoperative Checklist

o Patient Self Assessment

Completed by the patient prior to surgery for discussion
with the physician

o Acceptance Of Risk And Surgery Consent

Reviewed and initialed by the patient and physician and
retained in patient’s medical file

o Patient Surgery Record

Important pre- and postoperative appointments and related
information recorded by the patient

75
Postoperative Checklist

o Allergan Device Identification Card(s)

Supplied following surgery and retained by patient in designated
area of the Breast Reconstruction Surgery Planner

o Device Tracking Enrollment Form

Completed and returned by the patient to Allergan in the
business reply envelope provided

o Optional ConfidencePlus ® Premier

Warranty Enrollment Form
Completed and returned by the patient to Allergan in the
business reply envelope provided

o Information For Your Healthcare Providers

Completed by the patient to give to her mammography
center and primary care physician

76
 A simple questionnaire to ensure you
understand the risks and benefits of surgery

assessment
patient self
Patient Self Assessment
Following your review of Section 1, Important Information for Women
About Breast Reconstruction with NATRELLE ® Silicone-Filled Breast
Implants, use this Patient Self Assessment to evaluate your understanding
of the i­nformation presented. Be sure to bring this breast surgery planner
with the completed Patient Self Assessment to your consultation with your
doctor. He or she will review the assessment and use it to help guide
additional discussion about the risks and benefits of surgery. There is
­additional space at the end of the self assessment to make notes about
the information or record specific questions that you would like to discuss
with your surgeon.

Each of the following statements is clearly true or false. Indicate your answers
by checking true or false. Your surgeon will review your answers with you.

If signs of rupture are seen on an MRI, you should have

your implant removed.
o TRUE o FALSE

Additional surgery to your breast and/or implant will be

likely over the course of your life.
o TRUE o FALSE

Your implants are not considered lifetime devices and

you will likely undergo implant removal, with or without
replacement, during your life.
o TRUE o FALSE

You should inform your mammographers about the presence

of your implants.
o TRUE o FALSE

Your breast implants may interfere with your ability to

successfully breastfeed.
o TRUE o FALSE

77
 You should perform breast self-examinations monthly and
should make sure you know how to distinguish the implant
from your breast tissue.
o TRUE o FALSE

Silicone gel-filled breast implants have not been clinically

tested in women with autoimmune diseases like lupus or
scleroderma.
o TRUE o FALSE

If you have serious health problems or conditions such as

a weakened immune system or compromised blood supply
to the breast, you should discuss with your surgeon whether
breast reconstruction surgery is appropriate for you.
o TRUE o FALSE

To detect possible silent rupture, an MRI is recommended

3 years following initial surgery and every 2 years thereafter.
o TRUE o FALSE

Although rare, there have been reports in the scientific

literature providing evidence that the silicone gel fill may
move beyond the fibrous capsule and into the breast tissue
or away from the breast (gel migration), particularly if the
scar capsule is ruptured, causing local complications such
as pain and neuropathy.
o TRUE o FALSE

Capsular contracture or hardening of the tissue surrounding

the breast implant may result in the need for additional surgery.
o TRUE o FALSE

78
ADDITIONAL QUESTIONS OR TOPICS I WANT

TO DISCUSS WITH MY SURGEON:

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

____________________________________________________________

79
80
Initial your acceptance of the risks of surgery
and provide your written consent

and surgery consent

acceptance of risk
Acceptance of Risk and Surgery Consent
Surgeon and patient initial each
SURGEON Patient

If signs of rupture are seen on an MRI, then

you should have your implant removed. ________ ________

Additional surgery to your breast and/or

implant will be likely over the course of
your life. ________ __________

Your implants are not considered lifetime

devices and you will likely undergo implant
removal, with or without replacement,
during your life. ________ _________

You should inform your mammography

technologist about the presence of
your implants. ________ __________

Your breast implants may interfere with

your ability to successfully breastfeed. ________ _________

You should perform breast self-examinations

monthly and should make sure you know
how to distinguish the implant from your
breast tissue. ________ __________

To monitor your breast implants for

silent rupture, an MRI is recommended
three (3) years following surgery and then
every two (2) years after that. ________ __________

The scar tissue or capsule that normally forms

around the implant may tighten (contracture)
and squeeze the implant, making your breast
feel firmer and sometimes painful. ________ __________

Allergan maintains a breast implant

device tracking database and your
participation in this database is
strongly recommended. ________ __________

81
Consent to Surgery
My surgeon has provided me with the RECONSTRUCTION SURGERY
WITH Natrelle ® SILICONE-FILLED BREAST IMPLANTS PATIENT
PLANNER to inform me prior to my surgery.

I have had adequate time to review and understand the information

presented in the RECONSTRUCTION SURGERY WITH SILICONE
GEL-FILLED BREAST IMPLANTS PATIENT PLANNER. My concerns and
questions have been addressed by my doctor. I have considered
alternatives to reconstruction surgery, including use of external prostheses
or surgery with saline-filled breast implants.

I am choosing to proceed with silicone gel-filled

breast implant surgery.

Patient Name (Printed):_____________________________________________

Patient Signature:_________________________________________________

Date:___________________________________________________________

Surgeon Name (Printed):____________________________________________

Surgeon Signature:________________________________________________

Date:___________________________________________________________

82
All the surgery information you need
in one convenient place

patient surgery
record
Patient Surgery Record
Use this section to record important dates and contact
information related to your breast surgery.

Pre-operative mammogram
baseline (if necessary):____________________________________________

Pre-operative appointment date:____________________________________

Surgery date:___________________________________________________

Surgery location:________________________________________________

Contact person at
surgery location: ________________________________________________

Contact phone number:___________________________________________

First post-operative
appointment date:_______________________________________________

Subsequent post-operative
appointment dates:_______________________________________________

83
MRIs are recommended at 3 years following
initial surgery and every 2 years thereafter to
monitor implant integrity.

Month and year of my first

scheduled MRI:__________________________________________________
Post-surgery mammogram
(6 months to 1 year following surgery):______________________________

Allergan Device Identification Card(s)

Information
Record information from your Allergan device identification card(s)
below and then place your card(s) in the pocket on the front cover of this
planner for a permanent record.

Catalog Number: Left____________________________________________

Catalog Number: Right___________________________________________

Serial Number: Left_______________________________________________

Serial Number: Right_____________________________________________

84
Important information your surgeon
is required to provide

device tracking
Device Tracking Instructions
NATRELLE ® Silicone-Filled Breast Implants are subject to device
tracking per federal regulation. Because your implant is a tracked
device, your healthcare provider is required to report certain
information to Allergan following surgery, including implant-specific
information like serial number and catalog number as well as the date
of surgery, implanting surgeon name and contact information and
patient-specific information.

The device tracking form is a 2-part document and the top portion
has been forwarded to Allergan by your surgeon. Upon receipt by
Allergan of the healthcare provider portion of the device tracking form,
you are entered in the device tracking database. The patient portion of
the form was supplied to you following surgery in order to complete
enrollment in Allergan’s device tracking database. Your device tracking
form should have stickers with information about your implant(s). If the
stickers are not already attached, use your patient/device ID card
supplied following surgery to enter the serial number (SN) and catalog
number (REF) of your implant(s). Allergan strongly encourages you to
participate in device tracking. As information regarding the long-term
safety of silicone gel-filled breast implants becomes available, your
participation will allow us to provide this information to you. If you do
not wish to participate in device tracking, check the indicated box and
Allergan will remove your personal information from the database.

If you do wish to participate in the device tracking program but do

not want Allergan to release your personal information to any third
parties, such as the FDA, please check the appropriate box.

Finally, please indicate if you received this patient planner and had
adequate time to review the information and consider your decision
to proceed with breast surgery. Your answer here will help us evaluate
the effectiveness of the communication program that Allergan has
developed and make improvements if needed.

Place your completed device tracking form in the envelope provided

and return it to Allergan.

85
 DEVICE TRACKING
NATRELLETM Silicone-Filled Breast Implants
71 S. Los Carneros Road Goleta, CA 93117
800.972.9378 f: 800.432.8803
I. Complete Upon Implant
Device and Surgery Information

DATE OF IMPLANTATION mm /dd /yy

Affix Left Device Tracking Label OR Fill In The Device Data

(Left) REF

(Left) SN
Reconstruction Augmentation
Revision

Affix Right Device Tracking Label OR Fill In The Device Data

(Right) REF

(Right) SN
Reconstruction Augmentation
Revision
IMPLANTING/EXPLANTING PHYSICIAN INFORMATION
LAST NAME FIRST NAME

ADDRESS CITY, STATE/PROVINCE ZIP/POSTAL CODE

E-MAIL TELEPHONE FAX

ATTENDING/FOLLOWING PHYSICIAN INFORMATION (if different from above)

LAST NAME FIRST NAME

ADDRESS CITY, STATE/PROVINCE ZIP/POSTAL CODE

E-MAIL TELEPHONE FAX

PATIENT INFORMATION
LAST NAME FIRST NAME

ADDRESS CITY, STATE/PROVINCE ZIP/POSTAL CODE

DATE OF BIRTH SOCIAL SECURITY NUMBER TELEPHONE

II. Complete if Device Discarded or Destroyed N/A

Device(s) on this form were discarded/destroyed prior to completion of this procedure
Date: mm /dd /yy Reason/Comments:
III. Complete if NATRELLETM Silicone-Filled Breast Implants Were Removed N/A
Explanted Device Information
Date of explant mm /dd /yy

(Left) Serial # Unknown (Right) Serial # Unknown

(Left) Ref # Unknown (Right) Ref # Unknown
Reason for removal Reason for removal
Original implant date: mm /dd /yy Unknown Original implant date: mm /dd /yy Unknown
Original implanting physician Unknown Original implanting physician Unknown

COMPLETE AND RETURN THIS PAGE TO ALLERGAN IN THE ATTACHED ENVELOPE

OR FAX TO 800.432.8803
L030-06
Page 1 – Send to Allergan

For reference only

86
 IMPORTANT: DO NOT ENLARGE, REDUCE OR MOVE the FIM and POSTNET barcodes. They are only valid as printed!
Special care must be taken to ensure FIM and POSTNET barcode are actual size AND placed properly on the mail piece
IMPORTANT:
to meet bothDOUSPS
NOTregulations
ENLARGE,andREDUCE OR MOVE
automation the FIM
compatibility and POSTNET barcodes. They are only valid as printed!
standards.
IMPORTANT: DO NOT
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care must REDUCE
be taken to ensure MOVE
ORFIM and the
POSTNET POSTNET
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actual sizeThey
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to meetcare USPS
bothmust beregulations and automation
taken to ensure compatibility
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barcode are actual size AND placed properly on the mail piece
to meet both USPS regulations and automation compatibility standards. NO POSTAGE
NECESSARY
IF MAILED
IN THE
UNITED STATESNO POSTA
NECESSA
NO POSTAG
IF MAILE
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NECESSARY IN THE
NO POSTAGEIF MAILED
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IF MAILED ST
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IF MAILED
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UNITED STATES
IN THE
BUSINESS REPLY MAIL UNITED STATES
FIRST-CLASS MAIL PERMIT NO. 1639 SANTA BARBARA, CA
POSTAGE WILL BE PAID BY ADDRESSEE
BUSINESS REPLY MAIL
FIRST-CLASS MAIL PERMIT NO. 1639 SANTA BARBARA, CA
PAID BY ADDRESSEE
BUSINESS
BUSINESS REPLY
REPLY MAIL
FIRST-CLASS MAIL POSTAGEPERMIT
MAIL WILL BENO. 1639 SANTA BARBARA, CA
FIRST-CLASS MAIL
BUSINESS REPLY MAIL PERMIT NO. 1639 SANTA BARBARA, CA
FIRST-CLASS MAIL
DEVICE TRACKING POSTAGE
PERMIT NO.
WILL1639 ADDRESSEE
BE PAID BYSANTA BARBARA, CA
POSTAGE WILL BE PAID BY ADDRESSEE
POSTAGE WILL BE PAID BY ADDRESSEE
ALLERGAN
71 S LOS CARNEROS
DEVICE RD
TRACKING
SANTA BARBARA
ALLERGAN
DEVICE CA 93117-9817
TRACKING
DEVICE TRACKING
DEVICE S LOS CARNEROS RD
ALLERGAN
71TRACKING
ALLERGAN
SANTA
ALLERGAN
71 S LOS LOSBARBARA
CARNEROS
71 SCARNEROS 93117-9817
RDCARD
71
SANTA SANTA
S LOS BARBARA
CARNEROS
BARBARA CA RDCA 93117-9817
93117-9817
SANTA BARBARA CA 93117-9817
Optional additional coverage
from a trusted industry leader

warranty
Optional ConfidencePlus® Premier
Warranty Form
Confidence…it’s more than a sense of well-being.

It’s the peace of mind that comes with the knowledge your breast
implants are covered by an industry-leading warranty program. Allergan
ConfidencePlus® breast implant limited warranty programs offer you
coverage in the event of implant rupture, including product replacement
and financial assistance to cover expenses not reimbursed by your
insurance carrier.

Our standard ConfidencePlus® applies automatically to every NATRELLE®

breast implant recipient and includes lifetime product replacement and up
to $1200 in financial assistance subject to the conditions discussed in the
ConfidencePlus® literature.

The optional ConfidencePlus® Premier breast implant limited warranty

provides all the peace of mind included with our standard ConfidencePlus®
program, but increases the financial assistance to $2400 and offers free
contralateral implant replacement. For the low enrollment fee of $100, you
have access to lifetime product replacement, 10 years of coverage, the
freedom to change styles or size as part of your replacement surgery, free
contralateral implant replacement and up to $2400 in financial assistance.1

That’s peace of mind…that’s ConfidencePlus® Premier!

To enroll in our optional ConfidencePlus® Premier breast implant limited

warranty program, use the information contained on your Allergan device
identification card(s) supplied to you after surgery or complete the purchase
form that follows this page. Once complete, detach the form from this breast
surgery planner and return to Allergan in the envelope provided. You may
also fax your completed enrollment form with credit card information to
888.647.4029.

Your purchase form and $100 must be received or postmarked within 45

days of surgery and must accompany a certified check, money order, or
valid credit card number in order to process your purchase. Do not send a
personal check. ConfidencePlus® Premier enrollment forms that accompany
a personal check will not be processed.

1
A charge may apply on product with a higher list price. The optional ConfidencePlus®
Premier warranty is non-transferable and non-refundable. For complete program details see
the ConfidencePlus® warranty program and terms at www.allergan.com or call Allergan at
1.800.624.4261.

87
88
ConfidencePlus® Premier Limited Warranty Option
Mail or fax this completed enrollment form along with your payment to:
Allergan Warranty Processing
71 S. Los Carneros Road, Goleta, CA 93117
Fax 888.647.4029

Do not send a personal check. Enrollment forms that include a personal

check will not be processed.

To pay by credit card:

Credit Card Type: o Visa o MasterCard o American Express

Credit Card Number: _____________________________________________________

Expiration Date:__________________________________________________________

Cardholder Name (if other than Patient):______________________________________

Cardholder Signature:_____________________________________________________

To pay by certified check or money order:

Please make payable to: Allergan ConfidencePlus® Premier Limited Warranty
Name: _________________________________________________________________

Address:________________________________________________________________

City:____________________________________________________________________

State/Zip:_______________________________________________________________

Social Security Number: ___________________________________________________

Date of Birth:_____________________________________________________________

Home Phone:____________________________________________________________

Implanting Physician Name:________________________________________________

Physician Telephone: ______________________________________________________

Date of Surgery:__________________________________________________________

Implant Serial Number(s): Left Side___________________________________________

Implant Serial Number(s): Right Side__________________________________________

(The serial number follows the letters SN on your device identification card
provided by your surgeon.)

You will receive a certificate verifying your enrollment in the ConfidencePlus® Premier
Warranty. Please allow 8–10 weeks for processing.
Note: Enrollment in the ConfidencePlus® Premier Warranty may be voided if the information provided is
incorrect. The ConfidencePlus® Premier Warranty is non-refundable and non-transferable.
*For full details on the ConfidencePlus® Warranty and ConfidencePlus® Premier Warranty, refer to the
ConfidencePlus® Warranty Program & Terms, on www.allergan.com, or available from Allergan at
1.800.624.4261.

89
90
 IMPORTANT: DO NOT ENLARGE, REDUCE OR MOVE the FIM and POSTNET barcodes. They are only valid as printed!
Special care must be taken to ensure FIM and POSTNET barcode are actual size AND placed properly on the mail piece
IMPORTANT:
to meet bothDOUSPS
NOTregulations
ENLARGE, and automation compatibility
FIMstandards.
and POSTNET only valid as printed!
IMPORTANT: DO NOT ENLARGE, REDUCE REDUCE
OR MOVEOR theMOVE
FIM and
thePOSTNET barcodes. barcodes.
They are only
Theyvalid
are as printed!
Special Special
care must care
be must
taken be
to taken
ensure to
FIMensure
and FIM and
POSTNET
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barcode barcode
are actual are
sizeactual size
AND placed
barcodes. AND
They placed
properly
are properly
onlyon
valid
theasmail the mail piece
onpiece
printed!
Special both
to meetcare meet
USPS
to must both
be USPS
regulations
taken regulations
and automation
to ensure FIM and automation
and POSTNET compatibility
compatibility standards.
barcode standards.
are actual size AND placed properly on the mail piece
to meet both USPS regulations and automation compatibility standards. NO POSTAGE
NECESSARY
IF MAILED
IN THE
UNITED STATES NO POST
NECESSA
IF MAILE
NO POSTAG
NO POSTAGE
IN THE
NECESSAR
NONECESSARY
POSTAGE
UNITED
IF ST
MAILED
IF MAILED
NECESSARY
IN THE IN THE
IF MAILED
UNITED UNITED STAT
STATES
IN THE
BUSINESS REPLY MAIL UNITED STATES
FIRST-CLASS MAIL PERMIT NO. 1639 SANTA BARBARA, CA
POSTAGE WILL BE PAID BY ADDRESSEE
BUSINESS REPLY MAIL
FIRST-CLASS MAIL PERMIT NO. 1639 SANTA BARBARA, CA
POSTAGE WILL BE PAID BY ADDRESSEE
BUSINESS
BUSINESS REPLY
FIRST-CLASS
REPLY MAIL
MAIL PERMIT SANTA BARBARA, CA
FIRST-CLASS
BUSINESS MAIL MAIL PERMIT NO.
REPLY MAIL 1639 NO. 1639SANTA BARBARA, CA
FIRST-CLASS MAIL
DEVICE TRACKING PERMIT NO. 1639 SANTA BARBARA,
PAID BY ADDRESSEE CA
POSTAGEPOSTAGE
WILL BE PAID
WILL BY
BEADDRESSEE
POSTAGE WILL BE PAID BY ADDRESSEE
ALLERGAN
71 S LOS CARNEROS
WARRANTY RD
PROCESSING
BARBARA CA 93117-9817
SANTA ALLERGAN
DEVICEDEVICE TRACKING
TRACKING
DEVICE S LOS CARNEROS RD
71TRACKING
ALLERGAN
ALLERGAN
SANTA
ALLERGAN
71 LOSBARBARA
CARNEROSCA 93117-9817
71 S LOS SCARNEROS RD RD
71 S LOS
SANTA CARNEROS
SANTA BARBARA
BARBARA CA RDCA 93117-9817
93117-9817
SANTA BARBARA CA 93117-9817
Bring this information about your implant
surgery to your Mammography Center

mammography
information
Information for the Mammography Center
Please update my patient file to reflect the presence of NATRELLE ®
Silicone-Filled Breast Implants. Since the examination of breasts
reconstructed with breast implants requires more time, please allow
additional time when scheduling my next mammogram and alert the
physician and technologists performing the exam about the presence
of my implants.

You may be aware that the FDA has approved Allergan’s NATRELLE ®
Silicone-Filled Breast Implants for use in augmentation, reconstruction,
and revision surgery. As part of a women’s healthcare network, it is
important that you are aware of the latest information on the safety of
silicone gel-filled breast implants. For additional information, please
consider the following resources:

Institute of Medicine Report on the Safety of Silicone Breast Implants

www.nap.edu/catalog/9618.html

Food and Drug Administration

www.fda.gov/cdrh/breastimplants

Breast Implant Safety

www.breastimplantsafety.org

Patient Instructions
Please record the catalog and serial numbers exactly as they appear
on your Allergan device identification card(s) before giving this page
to your mammography center.

Location of implants
(submuscular or subglandular):_____________________________________

Catalog Number: Left____________________________________________

Catalog Number: Right___________________________________________

Serial Number: Left_______________________________________________

Serial Number: Right_____________________________________________

91
92
Provide this information to your Primary Care
Physician at your next scheduled appointment

care physician
to the primary
Information for Your Primary Care Physician
Your patient has been implanted with NATRELLE ® Silicone-Filled Breast
Implants. It is important that you include this information in her chart
because while silicone-filled breast implants have been proven safe in
thousands of patients worldwide, they can present additional challenges
for attending physicians. So to ensure your patient receives the care
she needs, when appropriate, please alert other physicians about the
presence of her implants.

You may be aware that the FDA has approved Allergan’s NATRELLE ®
Silicone-Filled Breast Implants for use in augmentation, reconstruction, and
revision surgery. As part of a women’s healthcare network, it is
important that you are aware of the latest information on the safety of
silicone gel-filled breast implants. For additional information, please
consider the following resources:

Institute of Medicine Report on the Safety of Silicone Breast Implants

www.nap.edu/catalog/9618.html

Food and Drug Administration

www.fda.gov/cdrh/breastimplants

Breast Implant Safety

www.breastimplantsafety.org

Patient Instructions
Please record the catalog and serial numbers exactly as they appear
on your Allergan device identification card(s) before giving this page
to your primary care physician. If you have multiple primary care
physicians, make copies of this form before providing to your physician.

Location of implants

(submuscular or subglandular):____________________________________

Catalog Number: Left___________________________________________

Catalog Number: Right__________________________________________

Serial Number: Left______________________________________________

Serial Number: Right____________________________________________

93
 .com

ALLERGAN
71 South Los Carneros Road, Santa Barbara, CA 93117

Tel: 1.800.624.4261
www.allergan.com

v003

© 2013 Allergan, Inc. ® and ™ marks owned by Allergan, Inc. LDOC-03991 Rev. 03